Product Code: DTD FDA class 2 21 CFR 870.3620

Pacemaker Lead Adaptor

Cardiovascular

The Pacemaker Lead Adaptor is an implantable cardiovascular accessory used to connect pacemaker leads of differing connector types or sizes to a pacemaker generator, enabling compatibility between components from different systems or generations. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTD and it is regulated under 21 CFR 870.3620 within the Cardiovascular medical specialty. This device is flagged as an implant.

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510(k)s

103

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DTD
Device Class: FDA class 2
Regulation Number: 870.3620
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 103 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K143463	IS4/DF4 Port Plug	Mar 19, 2015	Substantially Equivalent	Oscor, Inc.
K132008	6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP	Jul 30, 2013	Substantially Equivalent	Medtronic, Inc.
K041574	CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020	Jul 12, 2004	Substantially Equivalent	Guidant Corporation
K031164	PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV	Jun 19, 2003	Substantially Equivalent - Subject to Tracking Reg.	Oscor, Inc.
K024156	PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR	Jan 14, 2003	Substantially Equivalent	Oscor, Inc.
K010787	PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS	May 22, 2001	Substantially Equivalent	Oscor, Inc.
K003454	A1-CS-SB Y-ADAPTER, MODEL 124 871	Jan 18, 2001	Substantially Equivalent - Subject to Tracking Reg.	Biotronik, Inc.
K000210	MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT	Feb 23, 2000	Substantially Equivalent - Subject to Tracking Reg.	Medtronic Vascular
K982220	MODEL 2872 BIPOLAR LEAD ADAPTOR KIT	Oct 15, 1998	Substantially Equivalent - Subject to Tracking Reg.	Medtronic Vascular
K971930	BK-N SEALING CAP	Aug 14, 1997	Substantially Equivalent - Subject to Tracking & PMS	Biotronik, Inc.
K970388	A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE	Aug 14, 1997	Substantially Equivalent - Subject to Tracking & PMS	Biotronik, Inc.
K970204	BK-A; BK-B; BK-IS SEALING CAP	Apr 29, 1997	Substantially Equivalent	Biotronik, Inc.
K950140	IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069	Apr 06, 1995	Substantially Equivalent	Pacesetter, Inc.
K934899	BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM	May 12, 1994	Substantially Equivalent	Telectronics Pacing Systems, Inc.
K925168	MISCELLANEOUS PACING LEAD	May 03, 1994	Substantially Equivalent	Oscor Medical Corp.
K921318	ADAPTING SLEEVE KIT MODEL 4023	Aug 03, 1992	Substantially Equivalent	Siemens-Pacesetter, Inc.
K915724	MODEL 6984M LEAD EXTENDER KIT	Feb 18, 1992	Substantially Equivalent	Medtronic Vascular
K912773	UNIPOLAR UPSIZING ADAPTOR	Oct 23, 1991	Substantially Equivalent	Telectronics Pacing Systems, Inc.
K911142	LEAD TERMINAL PIN CAPS, VARIOUS MODELS	Aug 09, 1991	Substantially Equivalent	Biotronik, GmbH & Co.
K911302	MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT	Jul 30, 1991	Substantially Equivalent	Medtronic Vascular
K911827	MODEL 5866-9M & MODEL 6981M	Jul 23, 1991	Substantially Equivalent	Metronic, Inc.
K911048	MODEL 5857-3M LEAD END CAP KIT	Apr 18, 1991	Substantially Equivalent	Medtronic Vascular
K910630	MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT	Apr 18, 1991	Substantially Equivalent	Medtronic Vascular
K910112	BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR	Feb 25, 1991	Substantially Equivalent	Telectronics Pacing Systems, Inc.
K904575	MODEL 5866-37M LEAD ADAPTOR KIT	Feb 01, 1991	Substantially Equivalent	Medtronic Vascular
K902889	A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.	Aug 23, 1990	Substantially Equivalent	Biotronik, GmbH & Co.
K900512	SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS	Jun 25, 1990	Substantially Equivalent	Pacesetter Systems
K900627	MODEL 5866-34 LEAD ADAPTOR KIT	Apr 20, 1990	Substantially Equivalent	Medtronic Vascular
K896438	UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER	Apr 10, 1990	Substantially Equivalent	Telectronics Pacing Systems, Inc.
K900605	3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100	Mar 06, 1990	Substantially Equivalent	Possis Medical, Inc.
K890895	IMPLANTABLE ADAPTOR 033-380	Mar 06, 1990	Substantially Equivalent	Telectronics, Inc.
K895971	TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING	Feb 22, 1990	Substantially Equivalent	Telectronics Pacing Systems, Inc.
K894976	ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.	Oct 12, 1989	Substantially Equivalent	Medtronic Vascular
K894718	ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33	Sep 05, 1989	Substantially Equivalent	Intermedics, Inc.
K870562	DAIG PACEMAKER LEAD ADAPTOR	Mar 03, 1987	Substantially Equivalent	Daig Corp.
K862656	PACEMAKER LEAD ADAPTER	Jul 30, 1986	Substantially Equivalent	Cordis Corp.
K860832	MODEL 366-08 ADAPTAID CONNECTOR ADAPTER	Mar 31, 1986	Substantially Equivalent	Intermedics, Inc.
K854997	IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY	Feb 12, 1986	Substantially Equivalent	Telectronics, Inc.
K850968	MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN	Aug 29, 1985	Substantially Equivalent	Medtronic Vascular
K844814	BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD	Aug 29, 1985	Substantially Equivalent	Intermedics, Inc.
K851897	CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD	Aug 09, 1985	Substantially Equivalent	Cardiac Control Systems, Inc.
K852356	MEDTRONIC MODEL 5561	Aug 06, 1985	Substantially Equivalent	Medtronic Vascular
K852253	329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR	Jul 29, 1985	Substantially Equivalent	Cordis Corp.
K851458	MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD	Jul 11, 1985	Substantially Equivalent	Intermedics, Inc.
K851457	MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD	Jul 11, 1985	Substantially Equivalent	Intermedics, Inc.
K851890	MEDTRONIC 5064	Jun 19, 1985	Substantially Equivalent	Medtronic Vascular
K851665	PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE	May 21, 1985	Substantially Equivalent	Pacesetter Systems
K851145	PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD	Apr 19, 1985	Substantially Equivalent	Pacesetter Systems
K850652	PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD	Apr 10, 1985	Substantially Equivalent	Pacesetter Systems
K850576	PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR	Mar 06, 1985	Substantially Equivalent	Pacesetter Systems
K844974	MEDTRONIC 5061 ENDOCARDIAL PACING LEAD	Mar 06, 1985	Substantially Equivalent	Medtronic Vascular
K844857	PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD	Feb 14, 1985	Substantially Equivalent	Pacesetter Systems
K841451	BIOTRONIK DY-UNIPOLAR	Feb 07, 1985	Substantially Equivalent	Biotronik Sales, Inc.
K841450	BIOTRONIK DNP UNIPOLAR	Feb 07, 1985	Substantially Equivalent	Biotronik Sales, Inc.
K844687	MEDTRONIC MODEL 6912	Feb 01, 1985	Substantially Equivalent	Medtronic Vascular
K842145	TRANSVENOUS TINED VENTRICULAR LEAD	Jan 18, 1985	Substantially Equivalent	Medtronic Vascular
K842065	EPICARDIAL, UNIPOLAR LEAD 4951	Jan 18, 1985	Substantially Equivalent	Medtronic Vascular
K843703	PERMATHANE 865 & 867 UNIPOLAR POLYURETH	Jan 08, 1985	Substantially Equivalent	Pacesetter Systems
K841227	BIPOLAR ENDOCARDIAL LEAD 406L	Nov 27, 1984	Substantially Equivalent	Siemens Elema AB
K843060	SENTRA	Sep 20, 1984	Substantially Equivalent	Cardiac Pacemakers, Inc.
K841885	FASTPASS IMPLANTABLE ENDOCARDIAL PAC	Aug 03, 1984	Substantially Equivalent	Pacesetter Systems
K841739	MODEL 866 PERMATHANE BIPOLAR, COAXIAL	Aug 03, 1984	Substantially Equivalent	Pacesetter Systems
K840026	IMPLANTABLE ELECTRODE UNIPOLAR ADAPT	May 23, 1984	Substantially Equivalent	Telectronics, Inc.
K840025	IMPLANTABLE ELECTRODE BIPOLAR ADAPT	May 23, 1984	Substantially Equivalent	Telectronics, Inc.
K831160	LEAD ADAPTERS #'S 6016,6022,6017 ETC	May 09, 1983	Substantially Equivalent	Cardiac Pacemakers, Inc.
K822704	MODEL 366-07 ADAPT AID LEAD ADAPTER	Nov 24, 1982	Substantially Equivalent	Intermedics, Inc.
K821549	PACEMAKER 445 ADAPTER	Jun 02, 1982	Substantially Equivalent	Pacesetter Systems
K821548	PACEMAKER CONNECTOR PLUG	Jun 02, 1982	Substantially Equivalent	Pacesetter Systems
K821547	PACEMAKER UNIPOLAR ADAPTER	Jun 02, 1982	Substantially Equivalent	Pacesetter Systems
K820935	MODEL 5866-26 LEAD ADAPTER KIT	Apr 16, 1982	Substantially Equivalent	Medtronic Vascular
K813154	ADAPTING SLEEVE	Dec 02, 1981	Substantially Equivalent	Pacesetter Systems
K813152	ELECTRODE TERMINAL CAP	Dec 02, 1981	Substantially Equivalent	Pacesetter Systems
K813151	VITATRON INSERT	Dec 02, 1981	Substantially Equivalent	Pacesetter Systems
K812756	ADAPTAID #365-38	Oct 29, 1981	Substantially Equivalent	Intermedics, Inc.
K812812	INTERMEDICS ADAPTAID STEP-DOWN ADAPTER	Oct 27, 1981	Substantially Equivalent	Intermedics, Inc.
K811920	ADAPTAID LEAD ADAPTER, #365-17	Aug 13, 1981	Substantially Equivalent	Intermedics, Inc.
K811938	ADAPTAID LEAD ADAPTER #365-25	Aug 07, 1981	Substantially Equivalent	Intermedics, Inc.
K811349	MODEL 5866-24 LEAD ADAPTOR KIT	Jun 30, 1981	Substantially Equivalent	Medtronic Vascular
K810551	PACEMAKER LEAD ADAPTER	Apr 23, 1981	Substantially Equivalent	Pacesetter Systems
K810245	IMPLANTABLE PACEMAKER LEAD ADAPTER	Mar 04, 1981	Substantially Equivalent	Intermedics, Inc.
K802407	PACEMAKER LEAD ADAPTOR MODEL 431	Oct 31, 1980	Substantially Equivalent	Pacesetter Systems
K802077	UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER	Oct 23, 1980	Substantially Equivalent	Cardiac Pacemakers, Inc.
K801039	ADAPTAID HELICAL COIL ADAPTER 365-14	Jul 21, 1980	Substantially Equivalent	Intermedics, Inc.
K801038	ADAPTAID ELEMA LEAD ADAPTER KIT 365-17	Jul 08, 1980	Substantially Equivalent	Intermedics, Inc.
K801040	GE LEAD ADAPTER, MODEL 345-01	Jun 30, 1980	Substantially Equivalent	Intermedics, Inc.
K800353	ADAPTER KIT	May 28, 1980	Substantially Equivalent	Daig Corp.
K790218	BIPOLAR LEAD ADAPTOR, MODEL BA-415	Aug 10, 1979	Substantially Equivalent	Pacesetter Systems
K790436	IMPLANTABLE HEART LEAD TERMINAL ADAPTER	May 14, 1979	Substantially Equivalent	Arco Medical Products Co.
K790468	IMPLANTABLE HEART LEAD EXTENDER	Mar 19, 1979	Substantially Equivalent	Arco Medical Products Co.
K781824	ELECTRODE, MODEL 030-324/4 GUAGE	Feb 08, 1979	Substantially Equivalent	Telectronics, Inc.
K781823	ELECTRODE, MODEL 030-326	Feb 08, 1979	Substantially Equivalent	Telectronics, Inc.
K781822	ELECTRODE, MODEL 030-324	Feb 08, 1979	Substantially Equivalent	Telectronics, Inc.
K782097	ELECTRODE LEAD MODEL 030-198	Dec 22, 1978	Substantially Equivalent	Telectronics, Inc.
K781864	ADAPTER KIT	Dec 19, 1978	Substantially Equivalent	Daig Corp.
K781627	PACING LEAD ADAPTER MODEL ADB 21	Dec 08, 1978	Substantially Equivalent	R.E. Brown Co., Inc.
K781626	PACING LEAD ADAPTER, ACV 14, ACV 23	Dec 08, 1978	Substantially Equivalent	R.E. Brown Co., Inc.
K781622	PACING LEAD ADAPTER MODEL ACS 16	Dec 08, 1978	Substantially Equivalent	R.E. Brown Co., Inc.
K772058	LEAD ADAPTOR KIT MODEL 5866-21	Nov 03, 1977	Substantially Equivalent	Medtronic Vascular
K771642	ADAPTER A-413	Sep 14, 1977	Substantially Equivalent	Pacesetter Systems
K771641	UNIVERSAL LEAD ADAPTER, UA-414	Sep 14, 1977	Substantially Equivalent	Pacesetter Systems
K770478	ADAPTER, CORDIS	Mar 30, 1977	Substantially Equivalent	Cordis Corp.
K770199	LEAD EXTENDER MODEL 6516	Feb 07, 1977	Substantially Equivalent	Cardiac Pacemakers, Inc.
K770042	ADAPTER, LEAD, GENERAL ELECTRIC	Jan 12, 1977	Substantially Equivalent	Cardiac Pacemakers, Inc.