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 |
|---|---|---|---|
| Aug 23, 1994 | K942623 | TRIMPORT Gerard Medical Enterprises, Inc. | LJT |
| Aug 19, 1994 | K942412 | THEREX LOW-PROFILE PORT - TITANIUM MODEL Therex Corp. | LJT |
| Jul 26, 1994 | K942103 | L-CATH CATHETER SYSTEM - PORT L-CATH Luther Medical Products, Inc. | LJT |
| Jul 26, 1994 | K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM Pharmacia Deltec, Inc. | LJT |
| Jul 14, 1994 | K934796 | IPI LOW PROFILE IMPORT Pudenz-Schulte Medical Research Corp. | LJT |
| Jul 14, 1994 | K934167 | IPI DUAL LUMEN PORT Pudenz-Schulte Medical Research Corp. | LJT |
| Mar 22, 1994 | K936012 | THEREX LOW PROFILE PORT-TITANIUM MODEL Therex Corp. | LJT |
| Mar 22, 1994 | K934802 | THEREX LOW-PROFILE PORT-TITANIUM Therex Corp. | LJT |
| Mar 22, 1994 | K934792 | THEREX LOW-PROFILE PORT Therex Corp. | LJT |
| Feb 25, 1994 | K934640 | HMP DUAL POLYSULFONE PORT Horizon Medical Products, Inc. | LJT |
| Feb 25, 1994 | K934573 | HMP TITANIUM LOW PROFILE PORT Horizon Medical Products, Inc. | LJT |
| Feb 25, 1994 | K934504 | HMP DUAL TITANIUM PORT Horizon Medical Products, Inc. | LJT |
| Feb 25, 1994 | K933990 | HMP TITANIUM PORT Horizon Medical Products, Inc. | LJT |
| Feb 25, 1994 | K933986 | HMP POLYSULFONE PORT Horizon Medical Products, Inc. | LJT |
| Feb 25, 1994 | K931748 | CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS Tri-State Hospital Supply Corp. | LJT |
| Feb 25, 1994 | K930206 | PS MEDICAL IPI ACCESS KIT Pudenz-Schulte Medical Research Corp. | LJT |
| Feb 23, 1994 | K933350 | THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM Therex Corp. | LJT |
| Feb 23, 1994 | K933316 | THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM Therex Corp. | LJT |
| Feb 9, 1994 | K932447 | THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D. Therex Corp. | LJT |
| Feb 7, 1994 | K932671 | THEREX R-PORT Therex Corp. | LJT |
| Feb 3, 1994 | K932010 | V.A.D. ACCESS KIT Clinipad Corp. | LJT |
| Jan 7, 1994 | K932509 | STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT Strato Medical Corp. | LJT |
| Jan 5, 1994 | K932841 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS Pharmacia Deltec, Inc. | LJT |
| Jan 5, 1994 | K932840 | PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM Pharmacia Deltec, Inc. | LJT |
| Jan 5, 1994 | K932095 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S Pharmacia Deltec, Inc. | LJT |
| Oct 4, 1993 | K924250 | PLASTIC LOW PROFILE SUBCUTANEOUS PORT Bard Access Systems, Inc. | LJT |
| Jul 28, 1993 | K924748 | VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P Med Institute, Inc. | LJT |
| Jul 28, 1993 | K921902 | PORT ACCESS NEEDLE Kawasumi Laboratories Co., Ltd., JP | LJT |
| Jul 7, 1993 | K915273 | LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 Strato Medical Corp. | LJT |
| Jun 17, 1993 | K924505 | SNAP-LOCK MICROPORT - REVISED Strato Medical Corp. | LJT |
| May 6, 1993 | K925373 | THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D Therex Corp. | LJT |
| Apr 21, 1993 | K923019 | PHARMACIA DELTEC WINGED INFUSION SET Pharmacia Deltec, Inc. | LJT |
| Mar 20, 1993 | K922896 | VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL Med Institute, Inc. | LJT |
| Mar 19, 1993 | K926011 | A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI Therex Corp. | LJT |
| Dec 4, 1992 | K922147 | DUAL PLASTIC VASCULAR ACCESS SYSTEM Gerard Medical Enterprises, Inc. | LJT |
| Nov 25, 1992 | K920036 | SURECATH PORT ACCESS CATHETER Ivion Corp. | LJT |
| Nov 20, 1992 | K922419 | IPI IMPORT Pudenz-Schulte Medical Research Corp. | LJT |
| Nov 6, 1992 | K922434 | A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT Therex Corp. | LJT |
| Nov 6, 1992 | K921379 | A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT Therex Corp. | LJT |
| Oct 16, 1992 | K921475 | A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM Therex Corp. | LJT |
| Jul 21, 1992 | K921201 | VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST. Med Institute, Inc. | LJT |
| Nov 21, 1991 | K910448 | SNAP-LOCK MICRO PORT, MODIFICATION Infusaid Corp. | LJT |
| Sep 18, 1991 | K912702 | PLASTIC ATTACHABLE DUAL PORT Davol, Inc. | LJT |
| Aug 23, 1991 | K912540 | CONTOUR-PORT Ideal Medical, Inc. | LJT |
| Aug 9, 1991 | K913350 | VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM Med Institute, Inc. | LJT |
| Jul 30, 1991 | K912465 | VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121 Med Institute, Inc. | LJT |
| Jul 30, 1991 | K912424 | VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110 Med Institute, Inc. | LJT |
| Jul 30, 1991 | K912423 | VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112 Med Institute, Inc. | LJT |
| Jun 24, 1991 | K911449 | VITAL-PORT VASCULAR ACCESS SYSTEM Med Institute, Inc. | LJT |
| Apr 19, 1991 | K911055 | A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT Therex Corp. | LJT |
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