Product Code: DTB
FDA class 3
21 CFR 870.3680
Permanent Pacemaker Electrode
Cardiovascular
The Permanent Pacemaker Electrode is an implantable cardiovascular device consisting of a conductive lead placed in direct contact with cardiac tissue to deliver electrical stimulation from a pacemaker generator and sense intrinsic cardiac activity over the long term. It is classified as an FDA Class 3 device, the highest risk category, and requires Premarket Approval (PMA) before marketing. The product code is DTB and it is regulated under 21 CFR 870.3680 within the Cardiovascular medical specialty. This device is flagged as an implant.
510(k)s
487
FEI Numbers
24
Registration Numbers
24
Unique Applicants
53
Years Active
30
Research product code DTB in seconds
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Basic Information
- Product Code
- DTB
- Device Class
- FDA class 3
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 487 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS | Jul 10, 2006 | Substantially Equivalent | Biotronik, Inc. |
| K041809 | PERMANENT PACING LEAD, MODEL PY2 | Aug 06, 2004 | Substantially Equivalent | Oscor, Inc. |
| K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | Apr 07, 2004 | Substantially Equivalent | Oscor, Inc. |
| K031274 | MODEL 5071 MYOCARDIAL PACING LEAD | May 22, 2003 | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Vascular |
| K031210 | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD | May 16, 2003 | Substantially Equivalent | Metronic, Inc. |
| K023205 | ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP | Apr 24, 2003 | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, Inc. |
| K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | Jan 31, 2003 | Substantially Equivalent | Oscor, Inc. |
| K023803 | MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS | Dec 11, 2002 | Substantially Equivalent | Biotronik, Inc. |
| K023099 | AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP | Oct 18, 2002 | Substantially Equivalent | Biotronik, Inc. |
| K021217 | AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP | May 01, 2002 | Substantially Equivalent | Biotronik, Inc. |
| K010281 | MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP | Apr 09, 2002 | Substantially Equivalent | Biotronik, Inc. |
| K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | Mar 28, 2002 | Substantially Equivalent | Oscor, Inc. |
| K013339 | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS | Nov 08, 2001 | Substantially Equivalent - Subject to Tracking Reg. | Oscor, Inc. |
| K003918 | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES | May 22, 2001 | Substantially Equivalent - Subject to Tracking Reg. | Oscor, Inc. |
| K003072 | PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES | Jan 09, 2001 | Substantially Equivalent | Biotronik, Inc. |
| K001413 | ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 | Jun 02, 2000 | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, Inc. |
| K994240 | EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 | Apr 13, 2000 | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, Inc. |
| K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Apr 10, 2000 | Substantially Equivalent - Subject to Tracking Reg. | Ela Medical, Inc. |
| K000763 | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 | Apr 06, 2000 | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, GmbH & Co. |
| K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Apr 04, 2000 | Substantially Equivalent | Ela Medical, Inc. |
| K993139 | YP 45/15-BP; YP 53/15-BP; YP 60/15-BP | Dec 17, 1999 | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, Inc. |
| K990142 | HT, MODEL HT PB | Jul 30, 1999 | Substantially Equivalent - Subject to Tracking Reg. | Sulzer Oscor, Inc. |
| K991169 | SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 | Jul 01, 1999 | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, Inc. |
| K990483 | RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 | Jun 03, 1999 | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, Inc. |
| K980869 | SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 | Sep 10, 1998 | Substantially Equivalent | Biotronik, Inc. |
| K981083 | RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 | Jul 22, 1998 | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, Inc. |
| K972500 | TIR/TIJ AND POLYROX | Mar 04, 1998 | Substantially Equivalent - Subject to Tracking & PMS | Biotronik, Inc. |
| K972814 | LOCATOR MODEL 4036 | Feb 23, 1998 | Substantially Equivalent - Subject to Tracking Reg. | Pacesetter, Inc. |
| K965106 | ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 | Jan 27, 1998 | Substantially Equivalent - Subject to Tracking & PMS | Biotronik, Inc. |
| K972574 | STELA MODEL UJ45 PACING LEADS | Jan 08, 1998 | Substantially Equivalent - Subject to Tracking Reg. | Ela Medical, Inc. |
| K963738 | STELA MODEL BJ44 AND BJ45 PACING LEADS | May 23, 1997 | Substantially Equivalent - Subject to Tracking & PMS | Ela Medical, Inc. |
| K964107 | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR | Apr 01, 1997 | Substantially Equivalent - Subject to Tracking & PMS | Oscor Medical Corp. |
| K964604 | BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION | Mar 10, 1997 | Substantially Equivalent - Subject to Tracking & PMS | Biotronik, Inc. |
| K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD | Dec 16, 1996 | Substantially Equivalent - Subject to Tracking & PMS | Intermedics, Inc. |
| K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | Nov 04, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Intermedics, Inc. |
| K953044 | UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION | Sep 27, 1996 | Substantially Equivalent - Subject to Tracking & PMS | Biotronik, Inc. |
| K962036 | MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD | Aug 22, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Vascular |
| K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) | Aug 21, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Intermedics, Inc. |
| K961936 | MODEL 2188 CORONARY SINUS LEAD. | Aug 15, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Vascular |
| K961679 | TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS | Jul 30, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Vascular |
| K961118 | MAXIM PF MODELS 033-581/033-590 | Jul 15, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Telectronics Pacing Systems, Inc. |
| K943657 | STERILIZATION | Jun 24, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Telectronics Pacing Systems, Inc. |
| K955550 | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD | Jun 19, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Intermedics, Inc. |
| K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY | Jun 18, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Intermedics, Inc. |
| K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | Feb 27, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Intermedics, Inc. |
| K954714 | AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) | Feb 01, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Pacesetter, Inc. |
| K954551 | DF-1 TERMINAL CAP | Dec 26, 1995 | Substantially Equivalent - Subject to Tracking Reg. | Pacesetter, Inc. |
| K954085 | MODELS 5866-45 AND 5866-46 SIZING SLEEVE | Nov 07, 1995 | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Vascular |
| K951858 | TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS | Oct 12, 1995 | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Vascular |
| K952206 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING | Aug 31, 1995 | Unknown | Pacesetter, Inc. |
| K951950 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING | Aug 31, 1995 | Unknown | Pacesetter, Inc. |
| K951087 | TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD | Jun 29, 1995 | Substantially Equivalent - Subject to Tracking Reg. | Pacesetter, Inc. |
| K940703 | MEDTRONIC MODEL 4558M | Nov 04, 1994 | Unknown | Medtronic Vascular |
| K942440 | AFP CARDIAC PACING SYSTEM MODEL 283 | Aug 08, 1994 | Substantially Equivalent - Subject to Tracking Reg. | Siemens-Pacesetter, Inc. |
| K925038 | PACING LEAD MODEL 1188T | Jul 15, 1994 | Substantially Equivalent - Subject to Tracking Reg. | Siemens-Pacesetter, Inc. |
| K932892 | PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS | Jul 06, 1994 | Unknown | Siemens-Pacesetter, Inc. |
| K930876 | SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T | Jun 15, 1994 | Substantially Equivalent - Subject to Tracking Reg. | Siemens-Pacesetter, Inc. |
| K933055 | MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF | May 02, 1994 | Substantially Equivalent - Subject to Tracking & PMS | Medtronic Vascular |
| K933731 | MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD | Mar 21, 1994 | Substantially Equivalent | Medtronic Vascular |
| K932172 | MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS | Dec 08, 1993 | Unknown | Medtronic Vascular |
| K920662 | VASCOTWIST 9/60 | Nov 24, 1993 | Unknown | Vascor Medical Corp. |
| K931411 | MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L | Sep 23, 1993 | Substantially Equivalent | Medtronic Vascular |
| K913831 | VASCO TIP/VASCOFLANGE | Aug 25, 1993 | Substantially Equivalent | Vascor Medical Corp. |
| K914121 | VASCOSCREW 6/60 AND VASCOSCREW 8/60 | Aug 24, 1993 | Substantially Equivalent | Vascor Medical Corp. |
| K932254 | MAXIMA FILTERED HARDSHELL RESERVOIR | Aug 03, 1993 | Unknown | Medtronic Vascular |
| K925099 | POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA | Jun 22, 1993 | Substantially Equivalent | Possis Medical, Inc. |
| K925347 | MODEL 1148T TRANSVENOUS, SCREW-IN LEAD | Jun 10, 1993 | Substantially Equivalent | Siemens-Pacesetter, Inc. |
| K922042 | CARDIFIX ENDOCARDIAL PACING LEAD | Apr 29, 1993 | Unknown | Intermedics, Inc. |
| K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD | Jan 22, 1993 | Unknown | Intermedics, Inc. |
| K920822 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | Jan 22, 1993 | Unknown | Siemens-Pacesetter, Inc. |
| K915736 | MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING | Dec 03, 1992 | Unknown | Medtronic Vascular |
| K915188 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD | Sep 11, 1992 | Unknown | Cook Pacemaker Corp. |
| K914489 | NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING | Aug 17, 1992 | Substantially Equivalent | Telectronics Pacing Systems, Inc. |
| K921124 | MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS | May 22, 1992 | Unknown | Medtronic Vascular |
| K912464 | PERMANENT CARDIAC PACING LEADS AND ADAPTORS | Feb 11, 1992 | Substantially Equivalent | Medtronic Vascular |
| K912867 | OSCOR MEDICAL CORP PERMANENT PACING LEAD | Feb 04, 1992 | Substantially Equivalent | Oscor Medical Corp. |
| K915008 | PERMANENT PACING PAD, MODIFICATION | Jan 27, 1992 | Substantially Equivalent | Oscor Medical Corp. |
| K915007 | PERMANENT PACING LEADS, MODIFICATION | Jan 27, 1992 | Substantially Equivalent | Oscor Medical Corp. |
| K913288 | MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS | Oct 17, 1991 | Substantially Equivalent | Medtronic Vascular |
| K913393 | IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION | Sep 23, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K913205 | OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF | Sep 23, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K913204 | MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION | Sep 23, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K913203 | IMPLANT PACING LEAD TINED #3390, MODIFICATION | Sep 23, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K913202 | IMPLANT PACING LEAD, TINED #3262, MODIFICATION | Sep 23, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K913201 | PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION | Sep 23, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K913158 | MODIFIED OSCOR PY PACING LEADS/MODIFICATION | Sep 23, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K912235 | MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD | Sep 18, 1991 | Substantially Equivalent | Intermedics, Inc. |
| K911273 | 100 CM PERMANENT PACING LEAD MODELS | Aug 28, 1991 | Substantially Equivalent | Telectronics Pacing Systems, Inc. |
| K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE | Aug 28, 1991 | Substantially Equivalent | Pacesetter Systems |
| K910609 | PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP | Aug 28, 1991 | Substantially Equivalent | Biotronik, GmbH & Co. |
| K910528 | BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS | Aug 09, 1991 | Substantially Equivalent | Possis Medical, Inc. |
| K910608 | PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP | Jul 30, 1991 | Substantially Equivalent | Biotronik, GmbH & Co. |
| K905300 | PERMANENT PACING LEAD | May 07, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K905182 | OSCOR MEDICAL CORP. PERMANENT PACING PAD | May 07, 1991 | Substantially Equivalent | Oscor Medical Corp. |
| K903948 | INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD | Apr 22, 1991 | Substantially Equivalent | Intermedics, Inc. |
| K902672 | INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD | Mar 01, 1991 | Substantially Equivalent | Intermedics, Inc. |
| K904255 | FOCUS T41,T41F,T43, T43F,T44F | Jan 18, 1991 | Substantially Equivalent | Elamedical |
| K904741 | LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES | Jan 08, 1991 | Substantially Equivalent | Telectronics Pacing Systems, Inc. |
| K903221 | LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN | Nov 08, 1990 | Substantially Equivalent | Telectronics Pacing Systems, Inc. |
| K903929 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP | Oct 16, 1990 | Substantially Equivalent | Biotronik, GmbH & Co. |
| K903928 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP | Oct 16, 1990 | Substantially Equivalent | Biotronik, GmbH & Co. |
| K903927 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP | Oct 16, 1990 | Substantially Equivalent | Biotronik, GmbH & Co. |
| K902002 | MODELS 5069/5071 MYOCARDIAL PACING LEADS | Sep 26, 1990 | Substantially Equivalent | Medtronic Vascular |
| K900645 | LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING | Aug 08, 1990 | Substantially Equivalent | Telectronics Pacing Systems, Inc. |
| K896824 | BIOTRONIK'S PS-ENDOCARDIAL LEADS | Aug 08, 1990 | Substantially Equivalent | Biotronik, GmbH & Co. |
| K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T | Jul 17, 1990 | Substantially Equivalent | Pacesetter Systems |
| K896742 | FOCUS J81F, J83F, J41F, J43F PACING LEADS | Jul 17, 1990 | Substantially Equivalent | Ela Medical, Inc. |
| K901402 | VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 | Jun 12, 1990 | Substantially Equivalent | Telectronics Pacing Systems, Inc. |
| K901709 | DNP 60-B UNIPOLAR ENDOCARDIAL LEAD | May 22, 1990 | Substantially Equivalent | Biotronik, GmbH & Co. |
| K900984 | MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 | May 03, 1990 | Substantially Equivalent | Medtronic Vascular |
| K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T | Apr 20, 1990 | Substantially Equivalent | Pacesetter Systems |
| K896313 | MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. | Mar 06, 1990 | Substantially Equivalent | Medtronic Vascular |
| K895136 | PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA | Feb 08, 1990 | Substantially Equivalent | Medtronic Vascular |
| K897067 | MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES | Feb 05, 1990 | Substantially Equivalent | Telectronics Pacing Systems, Inc. |
| K892528 | FIVE-YEAR STERILE PACKAGING SHELF LIFE | Jan 18, 1990 | Substantially Equivalent | Daig Corp. |
| K896443 | MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS | Dec 20, 1989 | Substantially Equivalent | Possis Medical, Inc. |
| K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T | Dec 20, 1989 | Substantially Equivalent | Pacesetter Systems |
| K893041 | NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI | Nov 14, 1989 | Substantially Equivalent | Telectronics Pacing Systems, Inc. |
| K894040 | IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR | Jul 14, 1989 | Substantially Equivalent | Medtronic Vascular |
| K893763 | MODELS 1113 AND 1114 PACEMAKER LEADS | Jul 14, 1989 | Substantially Equivalent | Possis Medical, Inc. |
| K885175 | MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS | Jul 14, 1989 | Substantially Equivalent | Possis Medical, Inc. |
| K890018 | PACEMAKER LEAD ADAPTER | Jun 20, 1989 | Substantially Equivalent | Ela Medical, Inc. |
| K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | Jun 05, 1989 | Substantially Equivalent | Pacesetter Systems |
| K890644 | MEDTRONIC MODEL 5866-45 SIZING SLEEVE | May 31, 1989 | Substantially Equivalent | Medtronic Vascular |
| K890527 | ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS | Apr 21, 1989 | Substantially Equivalent | Medtronic Vascular |
| K884697 | HEPARIN BONDING FOR CATHETERS | Apr 19, 1989 | Substantially Equivalent | Daig Corp. |
| K890412 | MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS | Mar 28, 1989 | Substantially Equivalent | Intermedics, Inc. |
| K890411 | MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS | Mar 28, 1989 | Substantially Equivalent | Intermedics, Inc. |
| K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS | Mar 22, 1989 | Substantially Equivalent | Pacesetter Systems |
| K884811 | ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS | Feb 22, 1989 | Substantially Equivalent | Telectronics and Control Pacing Systems |
| K885240 | MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD | Feb 10, 1989 | Substantially Equivalent | Tpl-Cordis, Inc. |
| K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) | Feb 02, 1989 | Substantially Equivalent | Telectronics, Inc. |
| K890045 | MODEL 6208,6209,6210,6211,6212,6214 (PLI'S) | Jan 30, 1989 | Substantially Equivalent | Medtronic Vascular |
| K883743 | MEDTRONIC MODEL 4058 PACING LEAD | Jan 17, 1989 | Substantially Equivalent | Medtronic Vascular |
| K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 | Dec 15, 1988 | Substantially Equivalent | Telectronics, Inc. |
| K884394 | PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F | Dec 08, 1988 | Substantially Equivalent | Ela Medical, Inc. |
| K884005 | ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED | Dec 05, 1988 | Substantially Equivalent | Medtronic Vascular |
| K883070 | ENCOR UNIPOLAR VS-1 LEADS | Dec 05, 1988 | Substantially Equivalent | Cordis Leads, Inc. |
| K882462 | PERMANENT PACING LEAD MODEL RXBJ SERIES | Oct 28, 1988 | Substantially Equivalent | Oscor Medical Corp. |
| K882345 | PERMANENT PACING LEADS PYBJ SERIES | Oct 28, 1988 | Substantially Equivalent | Oscor Medical Corp. |
| K873772 | CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS | Oct 19, 1988 | Substantially Equivalent | Cordis Leads, Inc. |
| K884024 | POLYSAFE(TM) IMPLANTABLE PACING LEAD | Oct 14, 1988 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K883265 | MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD | Oct 14, 1988 | Substantially Equivalent | Telectronics and Cordis Pacing Systems |
| K881810 | MEDTRONIC MODEL 4951P | Oct 13, 1988 | Substantially Equivalent | Medtronic Vascular |
| K883015 | POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP | Oct 06, 1988 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K883016 | POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP | Sep 16, 1988 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K883602 | BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD | Sep 06, 1988 | Substantially Equivalent | Intermedics, Inc. |
| K883203 | MODEL 5866-34A PACEMAKER LEAD ADAPTOR | Sep 06, 1988 | Substantially Equivalent | Medtronic Vascular |
| K882452 | MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD | Aug 25, 1988 | Substantially Equivalent | Medtronic Vascular |
| K874366 | ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201 | Jun 16, 1988 | Substantially Equivalent | Cordis Leads, Inc. |
| K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 | May 31, 1988 | Substantially Equivalent | Telectronics, Inc. |
| K881712 | MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT | May 25, 1988 | Substantially Equivalent | Medtronic Vascular |
| K875178 | MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | May 25, 1988 | Substantially Equivalent | Intermedics, Inc. |
| K875100 | MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | May 24, 1988 | Substantially Equivalent | Intermedics, Inc. |
| K872126 | MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | Mar 22, 1988 | Substantially Equivalent | Intermedics, Inc. |
| K880551 | MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD | Mar 07, 1988 | Substantially Equivalent | Intermedics, Inc. |
| K875199 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR | Feb 18, 1988 | Substantially Equivalent | Biotronik Sales, Inc. |
| K872971 | PERMANENT MYOCARDIAL LEADS MP SERIES | Feb 12, 1988 | Substantially Equivalent | Oscor Medical Corp. |
| K874205 | ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T | Feb 02, 1988 | Substantially Equivalent | Pacesetter Systems |
| K873962 | MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD | Feb 02, 1988 | Substantially Equivalent | Medtronic Vascular |
| K874183 | ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD | Jan 29, 1988 | Substantially Equivalent | Daig Corp. |
| K874792 | MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD | Jan 19, 1988 | Substantially Equivalent | Medtronic Vascular |
| K874743 | PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390 | Jan 19, 1988 | Substantially Equivalent | Pace Medical |
| K874531 | POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD | Jan 07, 1988 | Substantially Equivalent | Intermedics, Inc. |
| K874930 | MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER | Jan 06, 1988 | Substantially Equivalent | Intermedics, Inc. |
| K874167 | MEDTRONIC PERMANENT LEAD INTRODUCER | Dec 07, 1987 | Substantially Equivalent | Medtronic Vascular |
| K873921 | MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE | Dec 03, 1987 | Substantially Equivalent | Intermedics, Inc. |
| K870885 | MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD | Nov 06, 1987 | Substantially Equivalent | Medtronic Vascular |
| K873931 | MODIFIED MODELS 1025M & 1026T PACING LEAD | Oct 22, 1987 | Substantially Equivalent | Pacesetter Systems |
| K872731 | PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 | Sep 15, 1987 | Substantially Equivalent | Ela Medical, Inc. |
| K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 | Aug 18, 1987 | Substantially Equivalent | Telectronics, Inc. |
| K870016 | ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) | May 28, 1987 | Substantially Equivalent | Migada, Ltd. |
| K871580 | IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 | May 22, 1987 | Substantially Equivalent | Intermedics, Inc. |
| K871625 | MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER | May 21, 1987 | Substantially Equivalent | Intermedics, Inc. |
| K870357 | ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY | May 21, 1987 | Substantially Equivalent | Intermedics, Inc. |
| K864618 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 | May 21, 1987 | Substantially Equivalent | Telectronics, Inc. |
| K871333 | IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL | May 06, 1987 | Substantially Equivalent | Medtronic Vascular |
| K870948 | MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD | Apr 10, 1987 | Substantially Equivalent | Intermedics, Inc. |
| K870824 | ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 | Mar 20, 1987 | Substantially Equivalent | Pacesetter Systems |
| K870610 | RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE | Mar 20, 1987 | Substantially Equivalent | Telectronics, Inc. |
| K870034 | MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD | Mar 03, 1987 | Substantially Equivalent | Oscor Medical Corp. |
| K864326 | MODEL 366-13 ADAPTAID STEP DOWN ADAPTER | Jan 16, 1987 | Substantially Equivalent | Intermedics, Inc. |
| K864856 | MODEL 5866-24 PACEMAKER LEAD ADAPTOR | Jan 06, 1987 | Substantially Equivalent | Medtronic Vascular |
| K864738 | MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP | Jan 06, 1987 | Substantially Equivalent | Intermedics, Inc. |
| K864640 | ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD | Jan 06, 1987 | Substantially Equivalent | Cordis Corp. |
| K864601 | CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD | Jan 06, 1987 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K864153 | PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 | Jan 06, 1987 | Substantially Equivalent | Pace Medical |
| K863536 | MEDTRONIC MODEL 5013 | Jan 06, 1987 | Substantially Equivalent | Medtronic Vascular |
| K862051 | MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD | Jan 06, 1987 | Substantially Equivalent | Intermedics, Inc. |
| K864564 | MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD | Dec 05, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K864428 | MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER | Dec 05, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K864098 | TELECTRONICS SREW-IN/SLIM LINE PACING LEADS | Dec 05, 1986 | Substantially Equivalent | Daig Corp. |
| K863921 | DAIG TYPE O4 VS-1 CONNECTOR | Nov 24, 1986 | Substantially Equivalent | Daig Corp. |
| K864287 | MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD | Nov 20, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K864002 | MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD | Nov 20, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K864048 | MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER | Nov 03, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K864047 | MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER | Nov 03, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K863781 | MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD | Nov 03, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K862966 | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) | Oct 31, 1986 | Substantially Equivalent | Oscor Medical Corp. |
| K863480 | BIOTRONIK PERMANENT PACEMAKER ELECTRODE | Sep 23, 1986 | Substantially Equivalent | Biotronik Sales, Inc. |
| K862054 | MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD | Sep 19, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K862053 | MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD | Sep 19, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K861493 | OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH | Aug 28, 1986 | Substantially Equivalent | Oscor Medical Corp. |
| K862330 | MODIFIED OSCOR PY PACING LEADS | Aug 08, 1986 | Substantially Equivalent | Oscor Medical Corp. |
| K851064 | CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR | Aug 05, 1986 | Substantially Equivalent | Cordis Corp. |
| K832422 | CORDIS ANCOR ACTIVE FIXATION LEAD | Aug 05, 1986 | Substantially Equivalent | Cordis Corp. |
| K861767 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-436 | Jul 18, 1986 | Substantially Equivalent | Telectronics, Inc. |
| K862443 | MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS | Jul 10, 1986 | Substantially Equivalent | Medtronic Vascular |
| K862259 | MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD | Jul 10, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K862258 | MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD | Jul 10, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K862257 | MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD | Jul 10, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K862052 | MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD | Jul 03, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K862276 | MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD | Jul 02, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K860846 | CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD | Jun 26, 1986 | Substantially Equivalent | Cordis Corp. |
| K854963 | S80 IMPLANTABLE CARDIAC PACING LEAD | Jun 24, 1986 | Substantially Equivalent | Sorin Biomedica, Fiat, USA, Inc. |
| K860548 | MODEL 492-02 ENDOCARDIAL PACING LEAD | Jun 13, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K860547 | MODEL 486-02 ENDOCARDIAL PACING LEAD | Jun 13, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K861481 | ENDOCARDIAL CARBON-TIP LEAD | Jun 06, 1986 | Substantially Equivalent | Pacesetter Systems |
| K861464 | LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS | May 19, 1986 | Substantially Equivalent | Pacesetter Systems |
| K861440 | LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO | May 13, 1986 | Substantially Equivalent | Pacesetter Systems |
| K853567 | DJP UNIPOLAR | May 07, 1986 | Substantially Equivalent | Biotronik Sales, Inc. |
| K853566 | DJ UNIPOLAR | May 07, 1986 | Substantially Equivalent | Biotronik Sales, Inc. |
| K861176 | MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER | Apr 29, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K861110 | MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER | Apr 23, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K860986 | MODEL 366-09 ADAPTAID ADAPTER SLEEVE | Mar 31, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K860985 | MODEL 366-19 ADAPTAID ADAPTER SLEEVE | Mar 31, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K854918 | MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD | Mar 11, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K854917 | MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD | Mar 11, 1986 | Substantially Equivalent | Intermedics, Inc. |
| K854128 | OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE | Feb 26, 1986 | Substantially Equivalent | Oscor Medical Corp. |
| K854142 | STYLET INTRODUCER FUNNEL | Jan 15, 1986 | Substantially Equivalent | Telectronics, Inc. |
| K853568 | DNR UNIPOLAR | Jan 15, 1986 | Substantially Equivalent | Biotronik Sales, Inc. |
| K854582 | MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016 | Jan 13, 1986 | Substantially Equivalent | Medtronic Vascular |
| K853446 | POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 | Jan 13, 1986 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K853747 | NAVIGATOR | Jan 08, 1986 | Substantially Equivalent | Mainsfield Scientific, Inc. |
| K854069 | POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD | Dec 09, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K854405 | PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD | Dec 04, 1985 | Substantially Equivalent | Pacesetter Systems |
| K854220 | PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD | Dec 04, 1985 | Substantially Equivalent | Pacesetter Systems |
| K854071 | POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD | Dec 04, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K853850 | EXPLORER | Dec 04, 1985 | Substantially Equivalent | Mansfield Scientific, Inc. |
| K853521 | POLYFLEX IMPLANTABLE PACING LEAD-476-07 | Dec 04, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K853517 | LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08 | Dec 04, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K853398 | MEDTRONIC MODEL 5062 | Dec 04, 1985 | Substantially Equivalent | Medtronic Vascular |
| K853294 | CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA | Dec 04, 1985 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K852710 | IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A | Dec 04, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K853914 | PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI | Dec 03, 1985 | Substantially Equivalent | Pacesetter Systems |
| K853518 | LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06 | Nov 05, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K853519 | LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03 | Oct 24, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K853520 | LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD | Oct 08, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K853411 | MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD | Oct 01, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K852708 | IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A | Oct 01, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K853223 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407 | Sep 17, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K853222 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402 | Sep 17, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K853221 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 | Sep 17, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K852709 | IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A | Sep 17, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K852446 | ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP | Sep 17, 1985 | Substantially Equivalent | Diag Corp. |
| K852972 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-400 | Sep 16, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K852119 | TEMPORARY PACEMAKER GROUND WIRE | Sep 15, 1985 | Substantially Equivalent | Scholten Surgical Instruments, Inc. |
| K851731 | ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 | Aug 29, 1985 | Substantially Equivalent | Ela Medical, Inc. |
| K852915 | SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 | Jul 29, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K851461 | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE | Jul 11, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K850623 | OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE | Apr 19, 1985 | Substantially Equivalent | Oscor Medical Corp. |
| K851296 | IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH | Apr 11, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K851297 | IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET | Apr 10, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K851295 | IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH | Apr 10, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K851294 | IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH | Apr 10, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K850065 | ELECATH TORKFLOAT PACING PROBE | Apr 10, 1985 | Substantially Equivalent | Electro-Catheter Corp. |
| K820267 | INTERMEDICS POLYFLEX PACING LEAD #480-01 | Apr 03, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K813136 | MODEL 492-01 PACEMAKER LEAD | Apr 03, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K813135 | MODEL 486-01 PACEMAKER LEAD | Apr 03, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K802294 | POLY FLEX IMPLANTABLE PACING LEAD | Apr 03, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844272 | MODEL 473-03 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844271 | MODEL 479-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844270 | MODEL 480-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844269 | MODEL 483-02 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844268 | MODEL 483-03 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844267 | MODEL 483-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844266 | MODEL 492-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844265 | MODEL 495-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844264 | MODEL 493-03 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844263 | MODEL 493-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844262 | MODEL 483-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844261 | MODEL 490-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844260 | MODEL 476-03 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844259 | MODEL 486-01 PACING LEAD | Mar 28, 1985 | Substantially Equivalent | Intermedics, Inc. |
| K844970 | CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS | Mar 27, 1985 | Substantially Equivalent | Cordis Corp. |
| K842032 | MODELS 4012/4512 TRANSVENOUS TINED- | Jan 18, 1985 | Substantially Equivalent | Medtronic Vascular |
| K842031 | TRANSVENOUS TINED VENTRICULAR/ATRIAL | Jan 18, 1985 | Substantially Equivalent | Medtronic Vascular |
| K844959 | MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN | Jan 10, 1985 | Substantially Equivalent | Medtronic Vascular |
| K843707 | MEDTRONIC 6957J | Jan 08, 1985 | Substantially Equivalent | Medtronic Vascular |
| K844752 | TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA | Jan 02, 1985 | Substantially Equivalent | Mansfield Scientific, Inc. |
| K843706 | MEDTRONIC 6957 | Dec 27, 1984 | Substantially Equivalent | Medtronic Vascular |
| K811259 | CORDIS ENCOR ATRIAL LEAD | Dec 27, 1984 | Substantially Equivalent | Cordis Corp. |
| K843394 | LIFELINE TLE 484-02 | Sep 24, 1984 | Substantially Equivalent | Intermedics, Inc. |
| K843393 | LIFELINE TLE 476-04 | Sep 24, 1984 | Substantially Equivalent | Intermedics, Inc. |
| K840668 | ELECTRODE PACEMAKER, PERM & TEMP | Sep 24, 1984 | Substantially Equivalent | Vitatron Medical BV |
| K834431 | PACING ELECTRODE | Mar 12, 1984 | Substantially Equivalent | Pacesetter Systems |
| K834342 | CCS MODEL AV-102 IMPLANTABLE A-V DATA | Feb 04, 1984 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K834533 | ELECTRODE LEAD CONSTRUCTION | Jan 30, 1984 | Substantially Equivalent | Telectronics, Inc. |
| K833824 | ENDOCARDIAL SCREW-IN LEAD 859 & 861 | Dec 01, 1983 | Substantially Equivalent | Pacesetter Systems |
| K833106 | BIOTRONIK DFH UNIPOLAR PE-60/4-DFH | Oct 20, 1983 | Substantially Equivalent | Biotronik Sales, Inc. |
| K833099 | BIOTRONIK N, BIPOLAR PEB-60/4-N | Oct 20, 1983 | Substantially Equivalent | Biotronik Sales, Inc. |
| K832987 | PERMANTHANE #866 BIPOLAR COAXIAL | Oct 20, 1983 | Substantially Equivalent | Pacesetter Systems |
| K831997 | IMPLANTABLE ENDOCARDIAL PACING LEADS | Oct 20, 1983 | Substantially Equivalent | Oscor, Inc. |
| K833108 | BIOTRONIK I-UNIPOLAR PE-60/2-13 | Oct 19, 1983 | Substantially Equivalent | Biotronik Sales, Inc. |
| K833104 | BIOTRONIK D2K UNIPOLAR PE-60/4 | Oct 19, 1983 | Substantially Equivalent | Biotronik Sales, Inc. |
| K833101 | BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC | Oct 19, 1983 | Substantially Equivalent | Biotronik Sales, Inc. |
| K833098 | BIOTRONIK DN UNIPOLAR PE-60/4-DN & | Oct 19, 1983 | Substantially Equivalent | Biotronik Sales, Inc. |
| K832409 | LIFELINE PACING LEADS #471-07 &09 | Aug 12, 1983 | Substantially Equivalent | Intermedics, Inc. |
| K832255 | MODEL F UNIPOLAR ENDOCARDIAL LEAD- | Aug 12, 1983 | Substantially Equivalent | Cook Pacemaker Corp. |
| K832245 | UNIPOLAR-E ENDOCARDIAL TINED LEAD | Aug 12, 1983 | Substantially Equivalent | Cook Pacemaker Corp. |
| K832110 | ELECTRODE LEADS 030-267 & 030-268 | Aug 12, 1983 | Substantially Equivalent | Telectronics, Inc. |
| K832099 | MEDTRONIC MODELS 4012 & 4512 | Jul 26, 1983 | Substantially Equivalent | Medtronic Vascular |
| K831767 | IMPLANTABLE CARDIAC PACING LEADS | Jul 26, 1983 | Substantially Equivalent | Oscor, Inc. |
| K831529 | CCS MODEL SJ-103 IMPLANTABLE ATRIAL | Jun 30, 1983 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K831436 | UNIPOLAR ATRIAL J PACING LEAD MODEL 869 | Jun 08, 1983 | Substantially Equivalent | Pacesetter Systems |
| K831435 | VENTRICULAR PACING LEADS MODELS 865/867 | Jun 08, 1983 | Substantially Equivalent | Pacesetter Systems |
| K831303 | TELECTRONICS #030-253 BIFURCATED | May 25, 1983 | Substantially Equivalent | William C. Nealon |
| K830743 | POROUS TIP ENDOCARDIAL LEAD | May 09, 1983 | Substantially Equivalent | Daig Corp. |
| K823898 | MODEL MF..D & MX..D PACEMAKER LEADS | Apr 30, 1983 | Substantially Equivalent | Oscor, Inc. |
| K823897 | MODEL SF. D&SX.D PACEMAKER LEADS | Apr 30, 1983 | Substantially Equivalent | Oscor, Inc. |
| K823896 | MODEL FF..D & FX..D PACEMAKER LEADS | Apr 30, 1983 | Substantially Equivalent | Dr. Ing. P. Osypka, GmbH |
| K823895 | MODEL RF. D&RX..D PACEMAKER LEADS | Apr 30, 1983 | Substantially Equivalent | Oscor, Inc. |
| K823894 | MODEL RZ PACEMAKER LEAD VARIOUS | Apr 30, 1983 | Substantially Equivalent | Dr. Ing. P. Osypka, GmbH |
| K823893 | MODEL MZ PACEMAKER LEAD-VARIOUS | Apr 30, 1983 | Substantially Equivalent | Oscor, Inc. |
| K823892 | MODEL SZ PACEMAKER LEAD-VARIOUS | Apr 30, 1983 | Substantially Equivalent | Dr. Ing. P. Osypka, GmbH |
| K823889 | MODEL JY PACEMAKER LEAD - VARIOUS | Apr 30, 1983 | Substantially Equivalent | Oscor, Inc. |
| K830828 | IMPLANTABLE PACING LEAD CCS MODEL SV-101 | Apr 28, 1983 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K830950 | VASCULAR PRODUCTS IMPLANTABLE PACING | Apr 18, 1983 | Substantially Equivalent | Oscor, Inc. |
| K830782 | LIFELINE ENDOCARDIAL PACING LEAD #479-05 | Apr 18, 1983 | Substantially Equivalent | Intermedics, Inc. |
| K823891 | MODEL KY PACEMAKER LEAD - VARIOUS | Mar 31, 1983 | Substantially Equivalent | Oscor, Inc. |
| K823890 | MODEL ZY PACEMAKER LEAD-VARIOUS | Mar 31, 1983 | Substantially Equivalent | Oscor, Inc. |
| K830457 | PACING LEAD #PMA F 860 | Mar 17, 1983 | Substantially Equivalent | Ela Medical, Inc. |
| K830464 | PACEMAKER ELECTRODE PERM. & TEMP | Mar 16, 1983 | Substantially Equivalent | Daig Corp. |
| K830463 | LIFELINE UNIPOLAR J-LEAD #483-05 | Feb 28, 1983 | Substantially Equivalent | Intermedics, Inc. |
| K823508 | LIFELINE -UNIPOLAR LEAD #487-05 | Jan 14, 1983 | Substantially Equivalent | Intermedics, Inc. |
| K823452 | ELECTRODE LEAD OF SILICONE ELASTOMETER | Jan 08, 1983 | Substantially Equivalent | Telectronics, Inc. |
| K823033 | ELECTRODE, PACEMAKER, PERMANENT | Dec 30, 1982 | Substantially Equivalent | Pacesetter Systems |
| K823448 | IMPLANTABLE PACING LEAD TINED #3390 & | Dec 03, 1982 | Substantially Equivalent | Oscor, Inc. |
| K823447 | IMPLANTABLE PACING LEAD, TINED #3262 & | Dec 03, 1982 | Substantially Equivalent | Vascular Products, Inc. |
| K823446 | PRODUCTS IMPLANTABLE PACING LEAD,TINED | Dec 03, 1982 | Substantially Equivalent | Oscor, Inc. |
| K822781 | MEDTRONIC MODELS 4011 & 4511 | Nov 30, 1982 | Substantially Equivalent | Medtronic Vascular |
| K822239 | COAXIAL BIPOLAR PACING ELECTRODE | Oct 04, 1982 | Substantially Equivalent | Burditt & Calkins-Siemens-Elema |
| K821947 | FASTPASS IMPLANTABLE ENDOCARD. PACING | Aug 06, 1982 | Substantially Equivalent | Pacesetter Systems |
| K821889 | POROUS SURFACED PLATINUM IRIDIUM | Aug 06, 1982 | Substantially Equivalent | Cordis Corp. |
| K820989 | MEDTRONIC #6993 | Aug 06, 1982 | Substantially Equivalent | Medtronic Vascular |
| K820487 | IMPLANTIBLE SUTURE SLEEVE | Apr 16, 1982 | Substantially Equivalent | Intermedics, Inc. |
| K820767 | BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 | Apr 09, 1982 | Substantially Equivalent | Siemens Elema AB |
| K812049 | STOCKERT CARDIAC PACING ELECTRODES | Mar 18, 1982 | Substantially Equivalent | Stoeckert Instrumente |
| K820262 | PERMANENT & TEMPORARY PACEMAKER ELECTR. | Mar 12, 1982 | Substantially Equivalent | Diag Corp. |
| K820121 | LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD. | Feb 12, 1982 | Substantially Equivalent | Telectronics, Inc. |
| K812905 | PERMANENT ENDOCARD. UNIPOLAR TINED LEAD | Feb 04, 1982 | Substantially Equivalent | Diag Corp. |
| K813205 | INTERSEPT CARDIOTOMY RESERVOIR/FILTER | Jan 28, 1982 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K812830 | APC IMPLANTABLE PACING LEAD | Jan 18, 1982 | Substantially Equivalent | American Pacemaker Corp. |
| K812807 | APC IMPLANTABLE PACING LEADS | Jan 18, 1982 | Substantially Equivalent | American Pacemaker Corp. |
| K813134 | ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP | Dec 10, 1981 | Substantially Equivalent | Telectronics, Inc. |
| K813028 | POLY-FLEX PACING LEADS | Dec 10, 1981 | Substantially Equivalent | Intermedics, Inc. |
| K810286 | PACEPATH IMPLANT. ENDOCARD. PACING LEAD | Nov 27, 1981 | Substantially Equivalent | Pacesetter Systems |
| K810139 | ELECTRODE, PACEMAKER, PERMANENT | Nov 27, 1981 | Substantially Equivalent | Pacesetter Systems |
| K812991 | INTERMEDICS POLYFLEX-MODEL 483-04 LEAD | Nov 16, 1981 | Substantially Equivalent | Intermedics, Inc. |
| K812990 | INTERMEDICS POLYFLEX-MODEL 483-03 LEAD | Nov 16, 1981 | Substantially Equivalent | Intermedics, Inc. |
| K812989 | INTERMEDICS POLYFLEX-MODEL 493-03 LEAD | Nov 16, 1981 | Substantially Equivalent | Intermedics, Inc. |
| K812816 | MODEL 841 ENDOCARDIAL TINED LEAD | Oct 29, 1981 | Substantially Equivalent | Pacesetter Systems |
| K812815 | MODEL 833 ENDOCARDIAL TINED LEAD | Oct 29, 1981 | Substantially Equivalent | Pacesetter Systems |
| K812599 | MEDTRONIC #4951 | Oct 23, 1981 | Substantially Equivalent | Medtronic Vascular |
| K811593 | ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J | Oct 13, 1981 | Substantially Equivalent | Telectronics, Inc. |
| K812245 | INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL | Oct 06, 1981 | Substantially Equivalent | Intermedics, Inc. |
| K812221 | INTERMEDICS POLY FLEX EPICARDIAL SUTURE | Oct 06, 1981 | Substantially Equivalent | Intermedics, Inc. |
| K812270 | PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL | Sep 16, 1981 | Substantially Equivalent | Diag Corp. |
| K811200 | PACEPATH IMPLANTABLE ENDOCARD. PACING LD | Aug 13, 1981 | Substantially Equivalent | Pacesetter Systems |
| K810494 | TYPE FH ENDOCARDIAL LEAD | Aug 07, 1981 | Substantially Equivalent | Biotronik Sales, Inc. |
| K811879 | MODEL A UNIPOLAR ENDOCARDIAL LEAD | Aug 03, 1981 | Substantially Equivalent | Cook Pacemaker Corp. |
| K811878 | MODEL B BIPOLAR ENDOCARDIAL LEAD | Aug 03, 1981 | Substantially Equivalent | Cook Pacemaker Corp. |
| K811877 | MODEL C UNIPOLAR ENDOCARDIAL LEAD | Aug 03, 1981 | Substantially Equivalent | Cook Pacemaker Corp. |
| K811876 | MODEL D BIPOLAR ENDOCARDIAL LEAD | Aug 03, 1981 | Substantially Equivalent | Cook Pacemaker Corp. |
| K810928 | ENDOCARDIAL ELECTRODE | Jul 02, 1981 | Substantially Equivalent | Vitatron Medical BV |
| K811539 | CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL | Jul 01, 1981 | Substantially Equivalent | Cordis Corp. |
| K811106 | INTERMEDICS POLY FLEX ENDOCARDIAL PACING | May 27, 1981 | Substantially Equivalent | Intermedics, Inc. |
| K810399 | APC IMPLANTABEL PACING LEAD, MODEL 3264 | May 15, 1981 | Substantially Equivalent | American Pacemaker Corp. |
| K810398 | APC IMPLANTABLE PACING LEAD, MODEL 3266 | May 15, 1981 | Substantially Equivalent | American Pacemaker Corp. |
| K810397 | APC IMPLANTABLE PACING LEAD-FLANGE #3260 | May 15, 1981 | Substantially Equivalent | American Pacemaker Corp. |
| K810396 | APC IMPLANTABLE PACING LEAD, TINED #3262 | May 15, 1981 | Substantially Equivalent | American Pacemaker Corp. |
| K810493 | TYPE N ENDOCARDIAL LEAD | Mar 20, 1981 | Substantially Equivalent | Biotronik Sales, Inc. |
| K810492 | TYPE YR ENDOCARDIAL LEAD | Mar 20, 1981 | Substantially Equivalent | Biotronik Sales, Inc. |
| K810491 | TYPE YC ENDOCARDIAL LEAD | Mar 20, 1981 | Substantially Equivalent | Biotronik Sales, Inc. |
| K810582 | ELECTRODE, PACEMAKER PERMANENT | Mar 13, 1981 | Substantially Equivalent | Pacesetter Systems |
| K810432 | CORDIS PERVENOUS ATRIAL LEAD | Mar 13, 1981 | Substantially Equivalent | Cordis Corp. |
| K810333 | TEMPORARY MYOCARDIAL PACING LEAD#6400 | Mar 13, 1981 | Substantially Equivalent | Medtronic Vascular |
| K802295 | POLY FLEX IMPLANTABLE PACING LEAD | Feb 09, 1981 | Substantially Equivalent | Intermedics, Inc. |
| K810202 | CORDIS MULTIFILAR PERVENOUS VENTRIC. LD | Feb 05, 1981 | Substantially Equivalent | Cordis Corp. |
| K802816 | ENDOCARDIAL LEADS 414S & 515S | Jan 16, 1981 | Substantially Equivalent | Siemens Elema AB |
| K802553 | PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN | Jan 16, 1981 | Substantially Equivalent | Daig Corp. |
| K802552 | PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE | Jan 16, 1981 | Substantially Equivalent | Daig Corp. |
| K802547 | PERMANENT & TEMP. PACEMAKER ELECTRODE | Jan 16, 1981 | Substantially Equivalent | Daig Corp. |
| K802413 | IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS | Jan 02, 1981 | Substantially Equivalent | Telectronics, Inc. |
| K803042 | SIEMENS-ELEMA ENDOCARDIAL LEAD 402S | Dec 22, 1980 | Substantially Equivalent | Siemens Elema AB |
| K802968 | UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC | Dec 22, 1980 | Substantially Equivalent | Telectronics, Inc. |
| K801284 | LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) | Dec 01, 1980 | Substantially Equivalent | Medtronic Vascular |
| K801172 | INTERMEDICS' LIFELINE TLE ENDOCARDIAL | Dec 01, 1980 | Substantially Equivalent | Intermedics, Inc. |
| K800870 | MEDTRONIC MODEL 6958 | Nov 13, 1980 | Substantially Equivalent | Medtronic Vascular |
| K802293 | POLYFLEX IMPLANTABLE PACING LEAD | Oct 31, 1980 | Substantially Equivalent | Intermedics, Inc. |
| K801416 | PACEPATH MODEL 810 | Oct 31, 1980 | Substantially Equivalent | Pacesetter Systems |
| K801792 | IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC. | Oct 23, 1980 | Substantially Equivalent | Telectronics, Inc. |
| K801455 | LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM | Oct 23, 1980 | Substantially Equivalent | Pacesetter Systems |
| K801417 | PACEPATH MODEL 819 | Oct 23, 1980 | Substantially Equivalent | Pacesetter Systems |
| K800944 | MEDTRONIC MODEL 69575 | Sep 26, 1980 | Substantially Equivalent | Medtronic Vascular |
| K800795 | PERMANENT & TEMP. PACEMAKER ELECTRODE | Jun 30, 1980 | Substantially Equivalent | Daig Corp. |
| K792301 | LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL | Jun 04, 1980 | Substantially Equivalent | Intermedics, Inc. |
| K792300 | LIFELINE TLE (TRAEBECULAR LODGING ELEC | Jun 04, 1980 | Substantially Equivalent | Intermedics, Inc. |
| K800354 | LEAD, TINED PACING, IMPLANTABLE | May 30, 1980 | Substantially Equivalent | Daig Corp. |
| K800891 | RESTERILIZATION OF IMPLANTABLE ELECTRODE | May 28, 1980 | Substantially Equivalent | Telectronics, Inc. |
| K800355 | LEAD, SUTURELESS MYOCARDIAL | May 28, 1980 | Substantially Equivalent | Daig Corp. |
| K800352 | PACEMAKER, ELECTRODE | May 28, 1980 | Substantially Equivalent | Daig Corp. |
| K800351 | PACEMAKER, ELECTRODE, PERM. & TEMP. | May 28, 1980 | Substantially Equivalent | Daig Corp. |
| K800350 | ENDOCARD. PACING LEAD STD. LENGTH PL202 | May 28, 1980 | Substantially Equivalent | Daig Corp. |
| K800349 | ENDOCARD. PACING LEAD LONG LENGTH PL200 | May 28, 1980 | Substantially Equivalent | Diag Corp. |
| K800348 | UNIPOLAR LEAD CONFIGURATION CONDUCTOR | May 28, 1980 | Substantially Equivalent | Daig Corp. |
| K800347 | PERM. INPLANT ENDOCARD. PAC. LEAD | May 28, 1980 | Substantially Equivalent | Daig Corp. |
| K792604 | LIFELINE TLE ENDOCARDIAL PACING LEAD, | Dec 31, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K792321 | IMPLANTABLE END. MUSH. TIP LEADS030-224 | Dec 13, 1979 | Substantially Equivalent | Telectronics, Inc. |
| K792387 | IMPLANTABLE ENDOCARDIAL TINED ELECTRODE | Dec 05, 1979 | Substantially Equivalent | Telectronics, Inc. |
| K792379 | CARDIAC PACING ELECTRODE | Dec 05, 1979 | Substantially Equivalent | Medi-Dyne Instruments, Inc. |
| K792168 | LIFELINE - ENDOCARDIAL PACING LEAD | Nov 13, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K791768 | CORDIS PERMANENT PERVENOUS CARDIAC LEADS | Nov 05, 1979 | Substantially Equivalent | Cordis Corp. |
| K791769 | MEDTRONIC MODEL 6957 | Sep 19, 1979 | Substantially Equivalent | Medtronic Vascular |
| K791732 | IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC | Sep 19, 1979 | Substantially Equivalent | Oscor, Inc. |
| K790143 | VENTRICULAR LEAD, MODEL 6959 | Sep 19, 1979 | Substantially Equivalent | Medtronic Vascular |
| K791378 | MODEL 482-01 BIPOLAR COAXIAL PACING LEAD | Sep 12, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K791377 | MODEL 484-01 BIPOLAR COAXIAL PACING LEAD | Sep 12, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K791667 | MEDTRONIC MODELS 69914/699OU | Sep 07, 1979 | Substantially Equivalent | Medtronic Vascular |
| K791552 | MODELS UL-804 AND BL-801 UNIPOLAR LEADS | Sep 04, 1979 | Substantially Equivalent | Pacesetter Systems |
| K790983 | BIFLEX TM TEMPORARY PACING PROBE | Jul 10, 1979 | Substantially Equivalent | Advanced Medical Concepts, Inc. |
| K790429 | MEDTRONIC MODEL 6957 | Jul 05, 1979 | Substantially Equivalent | Medtronic Vascular |
| K790988 | MODEL 6971 W/ DBS WIRE | Jun 11, 1979 | Substantially Equivalent | Medtronic Vascular |
| K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS | Jun 04, 1979 | Substantially Equivalent | Oscor, Inc. |
| K790548 | ENDOCARDIAL PACING LEAD, MODEL 476-01 | Jun 01, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K790766 | MEDTRONIC MODELS 6907/6901 | May 25, 1979 | Substantially Equivalent | Medtronic Vascular |
| K790344 | BIPOLAR PERNENOUS VENTRICULAR LEAD | Apr 17, 1979 | Substantially Equivalent | Cordis Corp. |
| K790462 | MEDTRONIC MODEL 6972 | Apr 16, 1979 | Substantially Equivalent | Medtronic Vascular |
| K790386 | LEAD MODELS MUM 1260, MUM 1290 | Apr 03, 1979 | Substantially Equivalent | Ela Medical, Inc. |
| K790074 | MEDTRONIC MODEL 6971 | Mar 29, 1979 | Substantially Equivalent | Medtronic Vascular |
| K790261 | MEDTRONIC TEMPTRON | Feb 27, 1979 | Substantially Equivalent | Medtronic Vascular |
| K790116 | CARDIOTOMY RESERVOIR CR-2000 | Feb 08, 1979 | Substantially Equivalent | Delta Medical Industries |
| K781570 | SUTURELESS MUOCARDINE PACING LEADS 471 | Feb 01, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K781525 | ENDOCARIDAL PACING LEAD UNIPOLAR 477 | Feb 01, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K781499 | LIFELINE PACING LEAD MODEL 467-01 | Feb 01, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K781498 | LIFELINE BIPOLAR PACING LEAD MOD. 466-01 | Feb 01, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K781497 | LIFELINE PACING LEAD MODEL 465-01 | Feb 01, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K782087 | LEAD, SUTURELESS MYOCARDIAL | Jan 15, 1979 | Substantially Equivalent | Daig Corp. |
| K781624 | PACING LEAD MODEL BUS 860, BUS 890 | Dec 21, 1978 | Substantially Equivalent | R.E. Brown Co., Inc. |
| K782004 | LEAD, TIMED PACING, IMPLANTABLE | Dec 15, 1978 | Substantially Equivalent | Daig Corp. |
| K781625 | PACING LEAD MODEL MVM 860, MVM 890 | Dec 08, 1978 | Substantially Equivalent | R.E. Brown Co., Inc. |
| K781623 | PACING MODELS MUM 860, MUM 890 | Dec 08, 1978 | Substantially Equivalent | R.E. Brown Co., Inc. |
| K781621 | PACING LEAD MODELS, MAM 1260 MAM 1290 | Dec 08, 1978 | Substantially Equivalent | R.E. Brown Co., Inc. |
| K781620 | PACING LEAD MODELS, MDM 1060, MDM 1090 | Dec 08, 1978 | Substantially Equivalent | R.E. Brown Co., Inc. |
| K781619 | PACING LEAD MODELS SA, 350, SAM 500 | Dec 08, 1978 | Substantially Equivalent | R.E. Brown Co., Inc. |
| K781849 | ELECTRODES, IMPLANTABLE WITH ADAPTER | Dec 04, 1978 | Substantially Equivalent | Telectronics, Inc. |
| K781456 | ENDOCARDIAL BIPOLAR LEAD | Dec 04, 1978 | Substantially Equivalent | American Technology, Inc. |
| K781326 | UNIPOPLAR ENDOCARDIAL LEADS | Dec 04, 1978 | Substantially Equivalent | American Technology, Inc. |
| K781776 | PACING LEADS MODEL UL-811 AND UL-813 | Oct 27, 1978 | Substantially Equivalent | Pacesetter Systems |
| K780246 | PACEMAKER, ELECTRODE, PERMANENT & TEMP. | Aug 31, 1978 | Substantially Equivalent | Daig Corp. |
| K780623 | ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 | Jul 28, 1978 | Substantially Equivalent | Medtronic Vascular |
| K780622 | BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 | Jul 28, 1978 | Substantially Equivalent | Medtronic Vascular |
| K780621 | LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED | Jul 26, 1978 | Substantially Equivalent | Medtronic Vascular |
| K780569 | L-12, L-21, AND L-22 ELECTRODES | Jun 14, 1978 | Substantially Equivalent | Coratomic, Inc. |
| K780446 | SUTURELESS MYOCARDIAL PACING LEAD | May 19, 1978 | Substantially Equivalent | Medtronic Vascular |
| K772309 | ENDOCARDIAL PACING ELECTRODE | Feb 06, 1978 | Substantially Equivalent | Coratomic, Inc. |
| K772197 | PACEMAKER, PERM. & TEMP., ELECTRODE | Jan 30, 1978 | Substantially Equivalent | Daig Corp. |
| K772331 | RESTERIL. OF IMPLANT. ELECT. & ADAPTER | Jan 11, 1978 | Substantially Equivalent | Telectronics, Inc. |
| K772203 | VENTRICULAR LEADS | Jan 11, 1978 | Substantially Equivalent | Medtronic Vascular |
| K772104 | PACING LEAD MODEL 6991A | Nov 28, 1977 | Substantially Equivalent | Medtronic Vascular |
| K772103 | BIPOLAR LEADS, DISP. | Nov 21, 1977 | Substantially Equivalent | Medtronic Vascular |
| K771567 | ENDOCARD. PACING LEAD-LONG LENGTH PL203 | Sep 14, 1977 | Substantially Equivalent | Daig Corp. |
| K771566 | ENDOCAR. PACING LEAD-STD. LENGTH PL202 | Sep 14, 1977 | Substantially Equivalent | Daig Corp. |
| K771565 | ENDOCARD. PACIN/ LEAD-LONG LENGTH PL200 | Sep 14, 1977 | Substantially Equivalent | Daig Corp. |
| K771564 | ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100 | Sep 14, 1977 | Substantially Equivalent | Daig Corp. |
| K771528 | CATHETER, CARDIAC PACING, ENDOCARDIAL | Aug 16, 1977 | Substantially Equivalent | American Technology, Inc. |
| K770468 | UNIPOLAR LEAD CONFIGURATION CONDUCTOR | Apr 05, 1977 | Substantially Equivalent | Daig Corp. |
| K770214 | TEMP. PERVENOUS LEAD W/REMOTE ANODE | Mar 28, 1977 | Substantially Equivalent | Cordis Corp. |
| K770416 | LEAD, HEART, BUTTERFLY CLAMP | Mar 10, 1977 | Substantially Equivalent | Arco Medical Products Co. |
| K770285 | BALL TIP, MODEL #030-188 | Feb 24, 1977 | Substantially Equivalent | Med Telectronics , Ltd. |
| K770284 | BALL TIP, MODEL #030-185 | Feb 24, 1977 | Substantially Equivalent | Med Telectronics , Ltd. |
| K770283 | WEDGE TIP, SMALL, MODEL #030-194 | Feb 24, 1977 | Substantially Equivalent | Med Telectronics , Ltd. |
| K770282 | WEDGE TIP, SMALL, MODEL #030-191 | Feb 24, 1977 | Substantially Equivalent | Med Telectronics , Ltd. |
| K770195 | PERM. IMPLANT. ENDOCARDIAL PAC. LEAD | Feb 07, 1977 | Substantially Equivalent | Daig Corp. |
| K760714 | ENDO-LOK L-40 ENDOCARDIAL PACING ELECT. | Dec 14, 1976 | Substantially Equivalent | Coratomic, Inc. |
| K760513 | ELECTRODE, TEMPORARY MYOCARDIAL | Oct 15, 1976 | Substantially Equivalent | Winn Hirsch & Assoc. |
| K760443 | CARDIAC ELECTRODE | Aug 26, 1976 | Substantially Equivalent | Meadox Medicals, Div. Boston Scientific Corp. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.