Panels › General Hospital › Product code LJT · Class 2
Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation 880.5965
1510(k)s in 12 months (288 all time)
1recalls in 12 months (141 all time)
131recalls that name a 510(k)
Top companies in LJT
| Company | 510(k)s | Recalls |
|---|---|---|
| Bard Peripheral Vascular, Inc. | 1 | 30 |
| Strato Medical Corp. | 27 | 0 |
| Therex Corp. | 24 | 0 |
| C.R. Bard, Inc. | 22 | 0 |
| ARROW INTERNATIONAL, LLC | 0 | 19 |
| Smiths Medical Asd, Inc. | 1 | 18 |
| Deltec, Inc | 0 | 18 |
| Navilyst Medical, Inc. | 4 | 14 |
| Med Institute, Inc. | 17 | 0 |
| Boston Scientific Corp | 8 | 8 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 1, 2007 | K062414 | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET Rita Medical Systems, Inc. | LJT |
| Jan 25, 2007 | K063377 | POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER C.R. Bard, Inc. | LJT |
| Jul 31, 2006 | K061424 | CELSITE/ CELSITE CONCEPT, ACCESS PORTS Aesculap, Inc. | LJT |
| Jul 14, 2006 | K060812 | POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE C.R. Bard, Inc. | LJT |
| May 17, 2006 | K060036 | PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER Smiths Medical MD, Inc. | LJT |
| Feb 2, 2006 | K043178 | GRANTALDER RHAPSODY ACCESS PORT AND CATHETER Grantadler Corportation | LJT |
| Apr 18, 2005 | K050310 | BARDPORT TITANIUM PORTS Bard Access Systems, Inc. | LJT |
| Feb 25, 2005 | K050176 | VORTEX EZ VASCULAR ACCESS PORT Rita Medical Systems, Inc. | LJT |
| Jan 23, 2004 | K033686 | PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM Smiths Medical MD, Inc. | LJT |
| Jan 15, 2004 | K034065 | MODIFICATION TO X-PORT DUO PORT C.R. Bard, Inc. | LJT |
| Nov 18, 2003 | K033473 | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT Horizon Medical Products, Inc. | LJT |
| Sep 12, 2003 | K032754 | VORTEX MP Horizon Medical Products, Inc. | LJT |
| Sep 9, 2003 | K032600 | VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 Boston Scientific Corp | LJT |
| Sep 9, 2003 | K032557 | TRIUMPH VTX WITH LIFEVALVE CATHETER Horizon Medical Products, Inc. | LJT |
| Aug 19, 2003 | K032375 | VAXCEL PORT, MODELS 45-336 AND 45-338 Boston Scientific Corp | LJT |
| Aug 5, 2003 | K031282 | OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 LeMaitre Vascular, Inc. | LJT |
| Jul 15, 2003 | K031844 | VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 Boston Scientific Corp | LJT |
| Jul 14, 2003 | K032008 | VAXCEL WITH PASV PORT, MODEL 45-213 Boston Scientific Corp | LJT |
| Jul 10, 2003 | K032044 | X-PROT DUO PORT C.R. Bard, Inc. | LJT |
| Jun 5, 2003 | K030636 | C-PORT Clinisurg Vascular Products, LLC | LJT |
| Feb 12, 2003 | K021580 | OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 LeMaitre Vascular, Inc. | LJT |
| Jan 28, 2003 | K030083 | VAXCEL WITH PASV PORT Boston Scientific Corp | LJT |
| Sep 25, 2002 | K022983 | BARDPORT X-PORT ISP PORT C.R. Bard, Inc. | LJT |
| Sep 12, 2002 | K022110 | KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. Kawasumi Laboratories, Inc. | LJT |
| Apr 10, 2001 | K010767 | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES Horizon Medical Products, Inc. | LJT |
| Mar 8, 2001 | K010426 | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER Sims Deltec, Inc. | LJT |
| Feb 12, 2001 | K010189 | VORTEX ACCESS SYSTEM Horizon Medical Products, Inc. | LJT |
| Oct 27, 2000 | K003006 | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION Arrow Intl., Inc. | LJT |
| Sep 26, 2000 | 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 Hdc Corp. | LJT |
| Apr 12, 2000 | K000125 | JET PORT PLUS CATHETER SYSTEM Clinical Plastic Products SA | LJT |
| Mar 13, 2000 | K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER B. Braun of America, Inc. | LJT |
| Feb 10, 2000 | K994196 | HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM Horizon Medical Products, Inc. | LJT |
| Jan 27, 2000 | K994216 | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM Sims Deltec, Inc. | LJT |
| Jan 3, 2000 | K994111 | CELSITE, MODELS ST401L, ST405L B. Braun/Mcgaw | LJT |
| Dec 3, 1999 | K993860 | CATHETER INNOVATIONS IMPLANTABLE PORT Catheter Innovations, Inc. | LJT |
| Nov 18, 1999 | K992697 | PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM Sims Deltec, Inc. | LJT |
| Oct 21, 1999 | K991897 | CATHETER INNOVATIONS IMPLANTABLE PORT Catheter Innovations, Inc. | LJT |
| Oct 19, 1999 | K992880 | P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM Sims Deltec, Inc. | LJT |
| Nov 23, 1998 | K983480 | BPOS-IVAD STABILIZER Bpos, Inc. | LJT |
| Oct 20, 1998 | K982888 | VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM Boston Scientific Corp | LJT |
| Sep 16, 1998 | K982507 | MINI POLYURETHANE CATHETER Med Institute, Inc. | LJT |
| May 7, 1998 | K974533 | TRIMPORT Gerard Medical, Inc. | LJT |
| Mar 2, 1998 | K974475 | THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 Biocontrol Technology, Inc. | LJT |
| Feb 12, 1998 | K974829 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) Kawasumi Laboratories Co., Ltd. | LJT |
| Jan 22, 1998 | K974471 | PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A Sims Deltec, Inc. | LJT |
| Jan 13, 1998 | K973497 | HUBERLOC Medcare Medical Group, Inc. | LJT |
| Dec 29, 1997 | K973862 | PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS Sims Deltec, Inc. | LJT |
| Dec 22, 1997 | K971582 | NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET Nipro Medical Corp. | LJT |
| Nov 17, 1997 | K971140 | VITAL-PORT INFUSION PAL Med Institute, Inc. | LJT |
| Apr 30, 1997 | K970442 | TARGET VITAL-PORT VASCULAR ACCESS SYSTEM Med Institute, Inc. | LJT |
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