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 |
|---|---|---|---|
| Mar 14, 1997 | K964117 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE Kawasumi Laboratories Co., Ltd. | LJT |
| Mar 10, 1997 | K964538 | R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM Boston Scientific Corp | LJT |
| Mar 6, 1997 | K964066 | DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) C.R. Bard, Inc. | LJT |
| Jan 3, 1997 | K964559 | PORTSMART NEEDLE DE-ACCESS ENCLOSURE Jireh, Inc. | LJT |
| Dec 16, 1996 | K962230 | CELSITE PORT WITH PRECONNECTED CATHETER B.Braun Medical, Inc. | LJT |
| Oct 24, 1996 | K963684 | A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED) Arrow Intl., Inc. | LJT |
| Oct 1, 1996 | K962695 | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER Sims Deltec, Inc. | LJT |
| Sep 30, 1996 | K962751 | IDEAS' DUAL PORT Ideas For Medicine, Inc. | LJT |
| Sep 20, 1996 | K961580 | PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS Sims Deltec, Inc. | LJT |
| Jul 19, 1996 | K961652 | LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017 Arrow Intl., Inc. | LJT |
| Jul 19, 1996 | K961615 | LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037 Arrow Intl., Inc. | LJT |
| Jul 18, 1996 | K961583 | A PORT DETACHED CATHETER SYSTEM CATALOG #1002 Arrow Intl., Inc. | LJT |
| May 24, 1996 | K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) Gerard Medical Enterprises, Inc. | LJT |
| Apr 26, 1996 | K960572 | THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER Arrow Intl., Inc. | LJT |
| Apr 17, 1996 | K952435 | CELSITE PEDIATRIC VENOUS SYSTEM B.Braun Medical, Inc., DE | LJT |
| Apr 15, 1996 | K960350 | THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 Biocontrol Technology, Inc. | LJT |
| Mar 21, 1996 | K955819 | A2 DETACHED DUAL PORT SYSTEM Arrow Intl., Inc. | LJT |
| Mar 21, 1996 | K955587 | VASCULAR ACCESS PORT KIT Boston Scientific Corp | LJT |
| Feb 12, 1996 | K955407 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS Sims Deltec, Inc. | LJT |
| Jan 26, 1996 | K953529 | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM Strato/Infusaid, Inc. | LJT |
| Dec 1, 1995 | K954297 | CELSITE VENOUS ACCESS SYSTEM OTW B.Braun Medical, Inc. | LJT |
| Nov 29, 1995 | K953254 | STRATO/INFUSAID INFUSE-A-KIT Strato/Infusaid, Inc. | LJT |
| Nov 15, 1995 | K954433 | VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM Gish Biomedical, Inc. | LJT |
| Nov 15, 1995 | K935767 | SIMS SILO NEEDLE DE-ACCESS ENCLOSURE Sims Deltec, Inc. | LJT |
| Oct 2, 1995 | K953571 | VASPORT VASCULAR ACCESS PORT Gish Biomedical, Inc. | LJT |
| Sep 19, 1995 | K953073 | LOW PROFILE TITANIUM MODEL CATALOG #1003 Arrow Intl., Inc. | LJT |
| Sep 13, 1995 | K953110 | LOW PROFILE TITANIUM MODEL CATALOG #1003 Therex Corp. | LJT |
| Sep 8, 1995 | K953017 | LOW PROFILE TITANIUM MODEL CATALOG #1003 Therex Corp. | LJT |
| Aug 29, 1995 | K951814 | TRIUMPH-1 PORT Horizon Medical Products, Inc. | LJT |
| Aug 10, 1995 | K952748 | AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** United States Surgical, A Division of Tyco Healthc | LJT |
| Jul 31, 1995 | K951077 | VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM Med Institute, Inc. | LJT |
| Jul 21, 1995 | K952548 | CELSITE VENOUS SYSTEM B.Braun Medical, Inc. | LJT |
| Jul 6, 1995 | K952537 | THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D. Therex Corp. | LJT |
| Jul 6, 1995 | K946189 | INTROPORT(TM) CATHETER MODEL #1000(ICT) Lifequest Medical, Inc. | LJT |
| Jun 13, 1995 | K951076 | VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM Med Institute, Inc. | LJT |
| May 31, 1995 | K945752 | CELSITE(TM) BRACHIAL VENOUS PORT B. Braun of America, Inc. | LJT |
| May 24, 1995 | K951875 | STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM Strato/Infusaid, Inc. | LJT |
| May 19, 1995 | K951874 | STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM Strato/Infusaid, Inc. | LJT |
| May 19, 1995 | K951873 | STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM Strato/Infusaid, Inc. | LJT |
| May 18, 1995 | K951872 | STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM Strato/Infusaid, Inc. | LJT |
| May 2, 1995 | K942784 | NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED Norfolk Medical Products, Inc. | LJT |
| Apr 21, 1995 | K945551 | CELSITE(TM) DUAL VENOUS SYSTEM B. Braun of America, Inc. | LJT |
| Apr 13, 1995 | K950212 | A2 DETACHED DUAL PORT SYSTEM Therex Corp. | LJT |
| Mar 23, 1995 | K950131 | 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL Therex Corp. | LJT |
| Mar 7, 1995 | K945250 | TRIMPORT Gerard Medical Enterprises, Inc. | LJT |
| Feb 1, 1995 | K942848 | STRATO MEDICAL LIFEPORT LPS 7515 Strato Medical Corp. | LJT |
| Jan 27, 1995 | K934518 | STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM Strato Medical Corp. | LJT |
| Jan 3, 1995 | K926139 | CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH Bard Access Systems, Inc. | LJT |
| Sep 19, 1994 | K932411 | VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA Med Institute, Inc. | LJT |
| Sep 6, 1994 | K934520 | VITAL-PORT VASCULAR ACCESS SYSTEM Med Institute, Inc. | LJT |
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