Product Code: LJT
FDA class 2
21 CFR 880.5965
Port & Catheter, Implanted, Subcutaneous, Intravascular
General Hospital
Port and Catheter, Implanted, Subcutaneous, Intravascular is a totally implantable vascular access system consisting of a subcutaneous port connected to an intravascular catheter, used to provide repeated long-term access to the bloodstream for administration of medications, fluids, blood products, or parenteral nutrition. It is an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LJT, regulated under 21 CFR 880.5965, within the General Hospital medical specialty. This device is an implant.
510(k)s
288
FEI Numbers
57
Registration Numbers
57
Unique Applicants
80
Years Active
43
Basic Information
- Product Code
- LJT
- Device Class
- FDA class 2
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
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 288 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260916 | FLEXI-PORT Power Injectable Implantable Port | Jun 17, 2026 | Substantially Equivalent | Portal Access, Inc. |
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | Sep 05, 2025 | Substantially Equivalent | Bard Access Systems, Inc. |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | Jun 18, 2025 | Substantially Equivalent | Bard Access Systems, Inc. |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | Oct 31, 2024 | Substantially Equivalent | Bard Access Systems, Inc. |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port | Dec 08, 2023 | Substantially Equivalent | Bard Peripheral Vascular, Inc. |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | May 22, 2020 | Substantially Equivalent | AngioDynamics, Inc. |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | Jul 08, 2019 | Substantially Equivalent | C.R. Bard, Inc. |
| K151239 | NMI DUAL PORT II | Jun 06, 2016 | Substantially Equivalent | Navilyst Medical, Inc. |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | May 20, 2016 | Substantially Equivalent | C.R. Bard, Inc. |
| K153238 | Dignity Dual Port | Mar 15, 2016 | Substantially Equivalent | Medcomp ( Medical Components) |
| K153228 | NMI Port, NMI Port II | Dec 04, 2015 | Substantially Equivalent | Navilyst Medical, Inc. |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | Nov 20, 2015 | Substantially Equivalent | C.R. Bard, Inc. |
| K150733 | Vital-Port Vascular Access System Power Injectable Port | May 21, 2015 | Substantially Equivalent | Cook Incorporated |
| K141146 | INVISIPORT | May 01, 2015 | Substantially Equivalent | Stealth Therapeutics, Incorporated |
| K140169 | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM | May 21, 2014 | Substantially Equivalent | Cook Incorporated |
| K133335 | POWERPORT IMPLANTABLE PORT | Feb 14, 2014 | Substantially Equivalent | C.R. Bard, Inc. |
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | Dec 12, 2013 | Substantially Equivalent | Medcomp ( Medical Components) |
| K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | Dec 11, 2013 | Substantially Equivalent | Perouse Medical |
| K131694 | NMI PORT II CATHETER | Aug 08, 2013 | Substantially Equivalent | Navilyst Medical, Inc. |
| K130923 | 5F DIGNITY CT TITANIUM PORT | Jul 31, 2013 | Substantially Equivalent | Medical Components, Inc. |
| K122402 | LPP (LOW PROFILE PORT) | Jul 16, 2013 | Substantially Equivalent | Pfm Medical, Inc. |
| K122767 | NMI PORT | Apr 30, 2013 | Substantially Equivalent | Navilyst Medical, Inc. |
| K130576 | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS | Apr 02, 2013 | Substantially Equivalent | B. Braun Interventional Systems, Inc. |
| K122899 | POWERPORT CLEARVUE SLIM IMPLANTABLE PORT | Nov 15, 2012 | Substantially Equivalent | C.R. Bard, Inc. |
| K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT | Sep 17, 2012 | Substantially Equivalent | Medical Components, Inc. |
| K110424 | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL | Nov 30, 2011 | Substantially Equivalent | Medcomp ( Medical Components) |
| K112713 | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS | Oct 27, 2011 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K110407 | INVISIPORT | Oct 13, 2011 | Substantially Equivalent | Stealth Therapeutics, Incorporated |
| K111101 | NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET | Aug 25, 2011 | Substantially Equivalent | Norfolk Medical |
| K102385 | NORFOLK MEDICAL NORPORT FAMILY OF PORTS | Jan 14, 2011 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K101017 | ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS | Jun 17, 2010 | Substantially Equivalent | AngioDynamics, Inc. |
| K093414 | PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS | Mar 01, 2010 | Substantially Equivalent | Smiths Medical Asd, Inc. |
| K091099 | C-PORT - HP POWER INJECTABLE PORT | May 22, 2009 | Substantially Equivalent | Phs Medical GmbH |
| K090512 | POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER | Mar 27, 2009 | Substantially Equivalent | C.R. Bard, Inc. |
| K082126 | RHAPSODY MRI | Nov 13, 2008 | Substantially Equivalent | Grantadler Corporation |
| K081889 | RHAPSODY CT | Nov 12, 2008 | Substantially Equivalent | Grantadler Corporation |
| K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT | Sep 30, 2008 | Substantially Equivalent | Cook Vascular, Inc. |
| K081472 | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS | Sep 23, 2008 | Substantially Equivalent | AngioDynamics, Inc. |
| K081311 | POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER | Jun 04, 2008 | Substantially Equivalent | C.R. Bard, Inc. |
| K080645 | STD MED PRIMO PORT POLY | May 02, 2008 | Substantially Equivalent | Std Med, Inc. |
| K072481 | JET PORT PLUS HP CATHETER SYSTEM | Mar 07, 2008 | Substantially Equivalent | Pfm Medical, Inc. |
| K073423 | MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER | Dec 19, 2007 | Substantially Equivalent | C.R. Bard, Inc. |
| K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS | Dec 14, 2007 | Substantially Equivalent | Smiths Medical MD, Inc. |
| K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT | Dec 12, 2007 | Substantially Equivalent | Pfm Medical, Inc. |
| K072549 | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER | Nov 14, 2007 | Substantially Equivalent | C.R. Bard, Inc. |
| K072215 | TITANIUM POWERPORT ISP IMPLANTED PORT | Nov 01, 2007 | Substantially Equivalent | C.R. Bard, Inc. |
| K071993 | T-PORT HP INFUSION PORT | Oct 17, 2007 | Substantially Equivalent | Pfm Medical, Inc. |
| K070911 | STD MED PRIMO PORT | Aug 10, 2007 | Substantially Equivalent | Std Med, Inc. |
| K070116 | POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE | May 23, 2007 | Substantially Equivalent | Smiths Medical MD, Inc. |
| K070003 | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) | May 15, 2007 | Substantially Equivalent | Medcomp |
| K062414 | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET | Feb 01, 2007 | Substantially Equivalent | Rita Medical Systems, Inc. |
| K063377 | POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER | Jan 25, 2007 | Substantially Equivalent | C.R. Bard, Inc. |
| K061424 | CELSITE/ CELSITE CONCEPT, ACCESS PORTS | Jul 31, 2006 | Substantially Equivalent | Aesculap, Inc. |
| K060812 | POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE | Jul 14, 2006 | Substantially Equivalent | C.R. Bard, Inc. |
| K060036 | PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER | May 17, 2006 | Substantially Equivalent | Smiths Medical MD, Inc. |
| K043178 | GRANTALDER RHAPSODY ACCESS PORT AND CATHETER | Feb 02, 2006 | Substantially Equivalent | Grantadler Corportation |
| K050310 | BARDPORT TITANIUM PORTS | Apr 18, 2005 | Substantially Equivalent | Bard Access Systems, Inc. |
| K050176 | VORTEX EZ VASCULAR ACCESS PORT | Feb 25, 2005 | Substantially Equivalent | Rita Medical Systems, Inc. |
| K033686 | PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM | Jan 23, 2004 | Substantially Equivalent | Smiths Medical MD, Inc. |
| K034065 | MODIFICATION TO X-PORT DUO PORT | Jan 15, 2004 | Substantially Equivalent | C.R. Bard, Inc. |
| K033473 | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT | Nov 18, 2003 | Substantially Equivalent | Horizon Medical Products, Inc. |
| K032754 | VORTEX MP | Sep 12, 2003 | Substantially Equivalent | Horizon Medical Products, Inc. |
| K032600 | VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 | Sep 09, 2003 | Substantially Equivalent | Boston Scientific Corp |
| K032557 | TRIUMPH VTX WITH LIFEVALVE CATHETER | Sep 09, 2003 | Substantially Equivalent | Horizon Medical Products, Inc. |
| K032375 | VAXCEL PORT, MODELS 45-336 AND 45-338 | Aug 19, 2003 | Substantially Equivalent | Boston Scientific Corp |
| K031282 | OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 | Aug 05, 2003 | Substantially Equivalent | LeMaitre Vascular, Inc. |
| K031844 | VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 | Jul 15, 2003 | Substantially Equivalent | Boston Scientific Corp |
| K032008 | VAXCEL WITH PASV PORT, MODEL 45-213 | Jul 14, 2003 | Substantially Equivalent | Boston Scientific Corp |
| K032044 | X-PROT DUO PORT | Jul 10, 2003 | Substantially Equivalent | C.R. Bard, Inc. |
| K030636 | C-PORT | Jun 05, 2003 | Substantially Equivalent | Clinisurg Vascular Products, LLC |
| K021580 | OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 | Feb 12, 2003 | Substantially Equivalent | LeMaitre Vascular, Inc. |
| K030083 | VAXCEL WITH PASV PORT | Jan 28, 2003 | Substantially Equivalent | Boston Scientific Corp |
| K022983 | BARDPORT X-PORT ISP PORT | Sep 25, 2002 | Substantially Equivalent | C.R. Bard, Inc. |
| K022110 | KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. | Sep 12, 2002 | Substantially Equivalent | Kawasumi Laboratories, Inc. |
| K010767 | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES | Apr 10, 2001 | Substantially Equivalent | Horizon Medical Products, Inc. |
| K010426 | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER | Mar 08, 2001 | Substantially Equivalent | Sims Deltec, Inc. |
| K010189 | VORTEX ACCESS SYSTEM | Feb 12, 2001 | Substantially Equivalent | Horizon Medical Products, Inc. |
| K003006 | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION | Oct 27, 2000 | Substantially Equivalent | Arrow Intl., Inc. |
| K002770 | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | Sep 26, 2000 | Substantially Equivalent | Hdc Corp. |
| K000125 | JET PORT PLUS CATHETER SYSTEM | Apr 12, 2000 | Substantially Equivalent | Clinical Plastic Products SA |
| K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER | Mar 13, 2000 | Substantially Equivalent | B. Braun of America, Inc. |
| K994196 | HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM | Feb 10, 2000 | Substantially Equivalent | Horizon Medical Products, Inc. |
| K994216 | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM | Jan 27, 2000 | Substantially Equivalent | Sims Deltec, Inc. |
| K994111 | CELSITE, MODELS ST401L, ST405L | Jan 03, 2000 | Substantially Equivalent | B. Braun/Mcgaw |
| K993860 | CATHETER INNOVATIONS IMPLANTABLE PORT | Dec 03, 1999 | Substantially Equivalent | Catheter Innovations, Inc. |
| K992697 | PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM | Nov 18, 1999 | Substantially Equivalent | Sims Deltec, Inc. |
| K991897 | CATHETER INNOVATIONS IMPLANTABLE PORT | Oct 21, 1999 | Substantially Equivalent | Catheter Innovations, Inc. |
| K992880 | P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM | Oct 19, 1999 | Substantially Equivalent | Sims Deltec, Inc. |
| K983480 | BPOS-IVAD STABILIZER | Nov 23, 1998 | Substantially Equivalent | Bpos, Inc. |
| K982888 | VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM | Oct 20, 1998 | Substantially Equivalent | Boston Scientific Corp |
| K982507 | MINI POLYURETHANE CATHETER | Sep 16, 1998 | Substantially Equivalent | Med Institute, Inc. |
| K974533 | TRIMPORT | May 07, 1998 | Substantially Equivalent | Gerard Medical, Inc. |
| K974475 | THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 | Mar 02, 1998 | Substantially Equivalent | Biocontrol Technology, Inc. |
| K974829 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) | Feb 12, 1998 | Substantially Equivalent | Kawasumi Laboratories Co., Ltd. |
| K974471 | PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A | Jan 22, 1998 | Substantially Equivalent | Sims Deltec, Inc. |
| K973497 | HUBERLOC | Jan 13, 1998 | Substantially Equivalent | Medcare Medical Group, Inc. |
| K973862 | PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS | Dec 29, 1997 | Substantially Equivalent | Sims Deltec, Inc. |
| K971582 | NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET | Dec 22, 1997 | Substantially Equivalent | Nipro Medical Corp. |
| K971140 | VITAL-PORT INFUSION PAL | Nov 17, 1997 | Substantially Equivalent | Med Institute, Inc. |
| K970442 | TARGET VITAL-PORT VASCULAR ACCESS SYSTEM | Apr 30, 1997 | Substantially Equivalent | Med Institute, Inc. |
| K964117 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE | Mar 14, 1997 | Substantially Equivalent | Kawasumi Laboratories Co., Ltd. |
| K964538 | R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM | Mar 10, 1997 | Substantially Equivalent | Boston Scientific Corp |
| K964066 | DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) | Mar 06, 1997 | Substantially Equivalent | C.R. Bard, Inc. |
| K964559 | PORTSMART NEEDLE DE-ACCESS ENCLOSURE | Jan 03, 1997 | Substantially Equivalent | Jireh, Inc. |
| K962230 | CELSITE PORT WITH PRECONNECTED CATHETER | Dec 16, 1996 | Substantially Equivalent | B.Braun Medical, Inc. |
| K963684 | A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED) | Oct 24, 1996 | Substantially Equivalent | Arrow Intl., Inc. |
| K962695 | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER | Oct 01, 1996 | Substantially Equivalent | Sims Deltec, Inc. |
| K962751 | IDEAS' DUAL PORT | Sep 30, 1996 | Substantially Equivalent | Ideas For Medicine, Inc. |
| K961580 | PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS | Sep 20, 1996 | Substantially Equivalent | Sims Deltec, Inc. |
| K961652 | LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017 | Jul 19, 1996 | Substantially Equivalent | Arrow Intl., Inc. |
| K961615 | LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037 | Jul 19, 1996 | Substantially Equivalent | Arrow Intl., Inc. |
| K961583 | A PORT DETACHED CATHETER SYSTEM CATALOG #1002 | Jul 18, 1996 | Substantially Equivalent | Arrow Intl., Inc. |
| K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) | May 24, 1996 | Substantially Equivalent | Gerard Medical Enterprises, Inc. |
| K960572 | THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER | Apr 26, 1996 | Substantially Equivalent | Arrow Intl., Inc. |
| K952435 | CELSITE PEDIATRIC VENOUS SYSTEM | Apr 17, 1996 | Substantially Equivalent | B.Braun Medical, Inc. |
| K960350 | THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 | Apr 15, 1996 | Substantially Equivalent | Biocontrol Technology, Inc. |
| K955819 | A2 DETACHED DUAL PORT SYSTEM | Mar 21, 1996 | Substantially Equivalent | Arrow Intl., Inc. |
| K955587 | VASCULAR ACCESS PORT KIT | Mar 21, 1996 | Substantially Equivalent | Boston Scientific Corp |
| K955407 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS | Feb 12, 1996 | Substantially Equivalent | Sims Deltec, Inc. |
| K953529 | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM | Jan 26, 1996 | Substantially Equivalent | Strato/Infusaid, Inc. |
| K954297 | CELSITE VENOUS ACCESS SYSTEM OTW | Dec 01, 1995 | Substantially Equivalent | B.Braun Medical, Inc. |
| K953254 | STRATO/INFUSAID INFUSE-A-KIT | Nov 29, 1995 | Unknown | Strato/Infusaid, Inc. |
| K954433 | VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM | Nov 15, 1995 | Substantially Equivalent | Gish Biomedical, Inc. |
| K935767 | SIMS SILO NEEDLE DE-ACCESS ENCLOSURE | Nov 15, 1995 | Substantially Equivalent | Sims Deltec, Inc. |
| K953571 | VASPORT VASCULAR ACCESS PORT | Oct 02, 1995 | Substantially Equivalent | Gish Biomedical, Inc. |
| K953073 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | Sep 19, 1995 | Substantially Equivalent | Arrow Intl., Inc. |
| K953110 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | Sep 13, 1995 | Substantially Equivalent | Therex Corp. |
| K953017 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | Sep 08, 1995 | Substantially Equivalent | Therex Corp. |
| K951814 | TRIUMPH-1 PORT | Aug 29, 1995 | Substantially Equivalent | Horizon Medical Products, Inc. |
| K952748 | AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** | Aug 10, 1995 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K951077 | VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM | Jul 31, 1995 | Substantially Equivalent | Med Institute, Inc. |
| K952548 | CELSITE VENOUS SYSTEM | Jul 21, 1995 | Substantially Equivalent | B.Braun Medical, Inc. |
| K952537 | THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D. | Jul 06, 1995 | Substantially Equivalent | Therex Corp. |
| K946189 | INTROPORT(TM) CATHETER MODEL #1000(ICT) | Jul 06, 1995 | Substantially Equivalent | Lifequest Medical, Inc. |
| K951076 | VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM | Jun 13, 1995 | Substantially Equivalent | Med Institute, Inc. |
| K945752 | CELSITE(TM) BRACHIAL VENOUS PORT | May 31, 1995 | Substantially Equivalent | B. Braun of America, Inc. |
| K951875 | STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM | May 24, 1995 | Substantially Equivalent | Strato/Infusaid, Inc. |
| K951874 | STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM | May 19, 1995 | Substantially Equivalent | Strato/Infusaid, Inc. |
| K951873 | STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM | May 19, 1995 | Substantially Equivalent | Strato/Infusaid, Inc. |
| K951872 | STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM | May 18, 1995 | Substantially Equivalent | Strato/Infusaid, Inc. |
| K942784 | NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED | May 02, 1995 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K945551 | CELSITE(TM) DUAL VENOUS SYSTEM | Apr 21, 1995 | Substantially Equivalent | B. Braun of America, Inc. |
| K950212 | A2 DETACHED DUAL PORT SYSTEM | Apr 13, 1995 | Substantially Equivalent | Therex Corp. |
| K950131 | 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL | Mar 23, 1995 | Substantially Equivalent | Therex Corp. |
| K945250 | TRIMPORT | Mar 07, 1995 | Substantially Equivalent | Gerard Medical Enterprises, Inc. |
| K942848 | STRATO MEDICAL LIFEPORT LPS 7515 | Feb 01, 1995 | Substantially Equivalent | Strato Medical Corp. |
| K934518 | STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM | Jan 27, 1995 | Unknown | Strato Medical Corp. |
| K926139 | CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH | Jan 03, 1995 | Substantially Equivalent | Bard Access Systems, Inc. |
| K932411 | VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA | Sep 19, 1994 | Substantially Equivalent | Med Institute, Inc. |
| K934520 | VITAL-PORT VASCULAR ACCESS SYSTEM | Sep 06, 1994 | Substantially Equivalent | Med Institute, Inc. |
| K942623 | TRIMPORT | Aug 23, 1994 | Substantially Equivalent | Gerard Medical Enterprises, Inc. |
| K942412 | THEREX LOW-PROFILE PORT - TITANIUM MODEL | Aug 19, 1994 | Substantially Equivalent | Therex Corp. |
| K942103 | L-CATH CATHETER SYSTEM - PORT L-CATH | Jul 26, 1994 | Substantially Equivalent | Luther Medical Products, Inc. |
| K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM | Jul 26, 1994 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K934796 | IPI LOW PROFILE IMPORT | Jul 14, 1994 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K934167 | IPI DUAL LUMEN PORT | Jul 14, 1994 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K936012 | THEREX LOW PROFILE PORT-TITANIUM MODEL | Mar 22, 1994 | Substantially Equivalent | Therex Corp. |
| K934802 | THEREX LOW-PROFILE PORT-TITANIUM | Mar 22, 1994 | Substantially Equivalent | Therex Corp. |
| K934792 | THEREX LOW-PROFILE PORT | Mar 22, 1994 | Substantially Equivalent | Therex Corp. |
| K934640 | HMP DUAL POLYSULFONE PORT | Feb 25, 1994 | Unknown | Horizon Medical Products, Inc. |
| K934573 | HMP TITANIUM LOW PROFILE PORT | Feb 25, 1994 | Unknown | Horizon Medical Products, Inc. |
| K934504 | HMP DUAL TITANIUM PORT | Feb 25, 1994 | Unknown | Horizon Medical Products, Inc. |
| K933990 | HMP TITANIUM PORT | Feb 25, 1994 | Unknown | Horizon Medical Products, Inc. |
| K933986 | HMP POLYSULFONE PORT | Feb 25, 1994 | Unknown | Horizon Medical Products, Inc. |
| K931748 | CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS | Feb 25, 1994 | Unknown | Tri-State Hospital Supply Corp. |
| K930206 | PS MEDICAL IPI ACCESS KIT | Feb 25, 1994 | Unknown | Pudenz-Schulte Medical Research Corp. |
| K933350 | THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM | Feb 23, 1994 | Unknown | Therex Corp. |
| K933316 | THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM | Feb 23, 1994 | Unknown | Therex Corp. |
| K932447 | THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D. | Feb 09, 1994 | Substantially Equivalent | Therex Corp. |
| K932671 | THEREX R-PORT | Feb 07, 1994 | Unknown | Therex Corp. |
| K932010 | V.A.D. ACCESS KIT | Feb 03, 1994 | Substantially Equivalent | Clinipad Corp. |
| K932509 | STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT | Jan 07, 1994 | Substantially Equivalent | Strato Medical Corp. |
| K932841 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS | Jan 05, 1994 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K932840 | PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM | Jan 05, 1994 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K932095 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S | Jan 05, 1994 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K924250 | PLASTIC LOW PROFILE SUBCUTANEOUS PORT | Oct 04, 1993 | Substantially Equivalent | Bard Access Systems, Inc. |
| K924748 | VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P | Jul 28, 1993 | Substantially Equivalent | Med Institute, Inc. |
| K921902 | PORT ACCESS NEEDLE | Jul 28, 1993 | Substantially Equivalent | Kawasumi Laboratories Co., Ltd. |
| K915273 | LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 | Jul 07, 1993 | Unknown | Strato Medical Corp. |
| K924505 | SNAP-LOCK MICROPORT - REVISED | Jun 17, 1993 | Substantially Equivalent | Strato Medical Corp. |
| K925373 | THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D | May 06, 1993 | Substantially Equivalent | Therex Corp. |
| K923019 | PHARMACIA DELTEC WINGED INFUSION SET | Apr 21, 1993 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K922896 | VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL | Mar 20, 1993 | Unknown | Med Institute, Inc. |
| K926011 | A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI | Mar 19, 1993 | Substantially Equivalent | Therex Corp. |
| K922147 | DUAL PLASTIC VASCULAR ACCESS SYSTEM | Dec 04, 1992 | Substantially Equivalent | Gerard Medical Enterprises, Inc. |
| K920036 | SURECATH PORT ACCESS CATHETER | Nov 25, 1992 | Substantially Equivalent | Ivion Corp. |
| K922419 | IPI IMPORT | Nov 20, 1992 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K922434 | A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT | Nov 06, 1992 | Substantially Equivalent | Therex Corp. |
| K921379 | A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT | Nov 06, 1992 | Substantially Equivalent | Therex Corp. |
| K921475 | A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM | Oct 16, 1992 | Substantially Equivalent | Therex Corp. |
| K921201 | VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST. | Jul 21, 1992 | Substantially Equivalent | Med Institute, Inc. |
| K910448 | SNAP-LOCK MICRO PORT, MODIFICATION | Nov 21, 1991 | Substantially Equivalent | Infusaid Corp. |
| K912702 | PLASTIC ATTACHABLE DUAL PORT | Sep 18, 1991 | Substantially Equivalent | Davol, Inc. |
| K912540 | CONTOUR-PORT | Aug 23, 1991 | Unknown | Ideal Medical, Inc. |
| K913350 | VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM | Aug 09, 1991 | Substantially Equivalent | Med Institute, Inc. |
| K912465 | VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121 | Jul 30, 1991 | Substantially Equivalent | Med Institute, Inc. |
| K912424 | VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110 | Jul 30, 1991 | Substantially Equivalent | Med Institute, Inc. |
| K912423 | VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112 | Jul 30, 1991 | Substantially Equivalent | Med Institute, Inc. |
| K911449 | VITAL-PORT VASCULAR ACCESS SYSTEM | Jun 24, 1991 | Substantially Equivalent | Med Institute, Inc. |
| K911055 | A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT | Apr 19, 1991 | Substantially Equivalent | Therex Corp. |
| K905852 | STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905850 | STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905849 | STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905845 | STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905843 | STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905842 | STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905841 | STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905840 | STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905839 | STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K905838 | STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED | Apr 19, 1991 | Unknown | Strato Medical Corp. |
| K911355 | LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 | Apr 15, 1991 | Substantially Equivalent | Strato Medical Corp. |
| K905848 | LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI | Apr 08, 1991 | Substantially Equivalent | Strato Medical Corp. |
| K905846 | STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION | Apr 08, 1991 | Substantially Equivalent | Strato Medical Corp. |
| K905851 | STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED | Apr 05, 1991 | Substantially Equivalent | Strato Medical Corp. |
| K905847 | STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION | Apr 05, 1991 | Substantially Equivalent | Strato Medical Corp. |
| K905844 | STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED | Apr 03, 1991 | Substantially Equivalent | Strato Medical Corp. |
| K905646 | OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY | Mar 27, 1991 | Substantially Equivalent | Norfolk Medical |
| K910005 | VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM | Mar 13, 1991 | Substantially Equivalent | Med Institute, Inc. |
| K904417 | CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM | Dec 05, 1990 | Substantially Equivalent | Device Labs, Inc. |
| K903364 | GERARD MEDICAL, INC. TRIM-PORT | Oct 31, 1990 | Unknown | Gerard Medical Enterprises, Inc. |
| K904077 | VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM | Oct 17, 1990 | Substantially Equivalent | Med Institute, Inc. |
| K903691 | A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX. | Oct 12, 1990 | Substantially Equivalent | Therex Corp. |
| K903220 | PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM | Oct 10, 1990 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K901419 | DUAL PORT | Sep 05, 1990 | Substantially Equivalent | Infusaid Corp. |
| K901722 | CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM | Jul 03, 1990 | Substantially Equivalent | Device Labs, Inc. |
| K895030 | LIFE-LINE(TM) VASCULAR ACCESS SYSTEM | Apr 17, 1990 | Unknown | Medical Engineering and Development Institute |
| K894650 | Q-PORT SYSTEM KIT | Mar 12, 1990 | Substantially Equivalent | Quinton, Inc. |
| K895689 | LIFEPORT VASCULAR ACCESS PORT | Dec 27, 1989 | Substantially Equivalent | Strato Medical Corp. |
| K896093 | A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT | Dec 06, 1989 | Substantially Equivalent | Therex Corp. |
| K895871 | LIFEPORT POLYURETHANE CATHETER | Nov 17, 1989 | Substantially Equivalent | Strato Medical Corp. |
| K893460 | A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM | Jun 23, 1989 | Substantially Equivalent | Therex Corp. |
| K891611 | MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH. | Jun 12, 1989 | Substantially Equivalent | Medtronic Versaflex, Inc. |
| K890518 | SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM | Apr 21, 1989 | Substantially Equivalent | Harbor Medical Devices, Inc. |
| K881342 | IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM | Aug 09, 1988 | Substantially Equivalent | Burron Medical, Inc. |
| K882230 | A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED | Jul 29, 1988 | Substantially Equivalent | Therex Corp. |
| K882190 | S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM | Jun 09, 1988 | Substantially Equivalent | Harbor Medical Devices, Inc. |
| K881075 | LIFEPORT II, MODEL LPS-1100 | Jun 03, 1988 | Substantially Equivalent | Strato Medical Corp. |
| K881745 | INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER | May 11, 1988 | Substantially Equivalent | Shiley Infusaid, Inc. |
| K880305 | LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH. | Apr 26, 1988 | Substantially Equivalent | Strato Medical Corp. |
| K881256 | NON CORING INFUSION SET | Apr 21, 1988 | Substantially Equivalent | Taris Corp. |
| K875276 | PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM | Apr 13, 1988 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K880571 | CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM | Mar 04, 1988 | Substantially Equivalent | Catheter Technology Corp. |
| K875213 | SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE | Mar 03, 1988 | Substantially Equivalent | Titan Medical, Inc. |
| K880297 | SEA - PORT INFUSION SET | Feb 19, 1988 | Substantially Equivalent | Harbor Medical Devices, Inc. |
| K875214 | A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM | Feb 19, 1988 | Substantially Equivalent | Therex Corp. |
| K874184 | CHEMO-PORT | Dec 30, 1987 | Substantially Equivalent | Hdc Corp. |
| K873575 | UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90 | Nov 13, 1987 | Substantially Equivalent | Healthcare Technologies, Inc. |
| K872329 | INFUSE-A-PORT ADDITIONAL SIZES | Nov 13, 1987 | Substantially Equivalent | Shiley Infusaid, Inc. |
| K873735 | MEDTRONIC CATHETER ACCESS PORT MODEL 8500 | Nov 03, 1987 | Substantially Equivalent | Medtronic Vascular |
| K873213 | HICKMAN PLASTIC SUBCUTANEOUS PORT | Oct 27, 1987 | Substantially Equivalent | C.R. Bard, Inc. |
| K872898 | POLYURETHANE CATHETER FOR THE INFUSE-A-PORT | Sep 15, 1987 | Substantially Equivalent | Shiley Infusaid, Inc. |
| K872838 | NORFOLK NORPORT (TM) -SP (SKIN PARALLEL) | Aug 25, 1987 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K872149 | SURECATH-ITP PERCUTANEOUS ACCESS KIT | Aug 04, 1987 | Substantially Equivalent | Titan Medical, Inc. |
| K870950 | UNIPORT MODEL SD-60, SD-70 | Aug 04, 1987 | Substantially Equivalent | Healthcare Technologies, Inc. |
| K870817 | MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT | Jul 30, 1987 | Substantially Equivalent | C.R. Bard, Inc. |
| K871209 | NORFOLK MEDICAL NORPORT | Jun 24, 1987 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K871192 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | Jun 10, 1987 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K870187 | NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT | May 07, 1987 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K870886 | LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER | May 06, 1987 | Substantially Equivalent | Strato Medical Corp. |
| K870519 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | Apr 15, 1987 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K870260 | HICKMAN TITANIUM SUBCUTANEOUS PORT | Apr 15, 1987 | Substantially Equivalent | C.R. Bard, Inc. |
| K864446 | PORT-A-CATH VASCULAR ACCESS SYSTEMS | Mar 31, 1987 | Substantially Equivalent | Pharmacia, Inc. |
| K864349 | MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT | Feb 10, 1987 | Substantially Equivalent | C.R. Bard, Inc. |
| K863750 | HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER | Dec 01, 1986 | Substantially Equivalent | C.R. Bard, Inc. |
| K853827 | LIFE-PORT IMPLANTABLE VASCULAR ACCESS | Nov 13, 1986 | Substantially Equivalent | Strato Medical Corp. |
| K863723 | NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT | Oct 29, 1986 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K863305 | HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER | Oct 10, 1986 | Substantially Equivalent | C.R. Bard, Inc. |
| K863296 | INFUSE-A-PORT EXPLANT KIT | Sep 11, 1986 | Substantially Equivalent | Intermedics/Infusaid, Inc. |
| K862018 | MICRO PORT | Sep 03, 1986 | Substantially Equivalent | Intermedics/Infusaid, Inc. |
| K853332 | HDC CHEMO-PORT (VASCULAR) | Jul 17, 1986 | Substantially Equivalent | Hdc Corp. |
| K861498 | MEDTRONIC MODEL 8501 ACCESS PORT | Jun 12, 1986 | Substantially Equivalent | Medtronic Vascular |
| K851293 | IMPLANTOFIX | Jan 09, 1986 | Substantially Equivalent | Burron Medical Products, Inc. |
| K853981 | INFUSAID INFUSE-A-PORT (MODIFIED) | Dec 18, 1985 | Substantially Equivalent | Intermedics/Infusaid, Inc. |
| K854019 | PORT-GARD | Nov 26, 1985 | Substantially Equivalent | Cormed, Inc., Sub. C.R.Bard, Inc. |
| K853322 | MEDTRONIC ACCESS PORT MODEL 8500 | Nov 06, 1985 | Substantially Equivalent | Medtronic Vascular |
| K850967 | STERILE CORMED MEDIPORT | May 17, 1985 | Substantially Equivalent | Cormed, Inc., Sub. C.R.Bard, Inc. |
| K850888 | PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV | May 07, 1985 | Substantially Equivalent | Creative Care Systems, Inc. |
| K840481 | INFUSE-A-PORT HEPARIN LOCK MAINT KIT | Sep 18, 1984 | Substantially Equivalent | Infusaid Corp. |
| K842355 | INFUSAID INFUSE-A-PORT | Aug 06, 1984 | Substantially Equivalent | Infusaid Corp. |
| K841679 | VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD | Jun 28, 1984 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K841150 | VASCULAR-ACCESS PORT CHANGE CATHETER | Apr 24, 1984 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K841149 | VASCULAR-ACCESS PORT - ENLARGEMENT | Apr 24, 1984 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K840788 | VASCULAR ACCESS PORT CHANGES IN MATER | Apr 24, 1984 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K832917 | PORT-A-CATH | Dec 28, 1983 | Substantially Equivalent | Pharmacia, Inc. |
| K832788 | INFUSE-A-PORT | Sep 15, 1983 | Substantially Equivalent | Infusaid Corp. |
| K830730 | PORT-A-CATH IMPLANTABLE CATH. SYS | Jun 30, 1983 | Substantially Equivalent | Pharmacia, Inc. |
| K830000 | VASCULAR-ACCESS-PORT | Mar 01, 1983 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K823838 | INFUSE-A-PORT | Jan 12, 1983 | Substantially Equivalent | Infusaid Corp. |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.