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 |
|---|---|---|---|
| Apr 19, 1991 | K905852 | STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905850 | STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905849 | STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905845 | STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905843 | STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905842 | STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905841 | STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905840 | STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905839 | STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED Strato Medical Corp. | LJT |
| Apr 19, 1991 | K905838 | STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED Strato Medical Corp. | LJT |
| Apr 15, 1991 | K911355 | LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 Strato Medical Corp. | LJT |
| Apr 8, 1991 | K905848 | LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI Strato Medical Corp. | LJT |
| Apr 8, 1991 | K905846 | STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION Strato Medical Corp. | LJT |
| Apr 5, 1991 | K905851 | STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED Strato Medical Corp. | LJT |
| Apr 5, 1991 | K905847 | STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION Strato Medical Corp. | LJT |
| Apr 3, 1991 | K905844 | STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED Strato Medical Corp. | LJT |
| Mar 27, 1991 | K905646 | OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY Norfolk Medical | LJT |
| Mar 13, 1991 | K910005 | VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM Med Institute, Inc. | LJT |
| Dec 5, 1990 | K904417 | CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM Device Labs, Inc. | LJT |
| Oct 31, 1990 | K903364 | GERARD MEDICAL, INC. TRIM-PORT Gerard Medical Enterprises, Inc. | LJT |
| Oct 17, 1990 | K904077 | VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM Med Institute, Inc. | LJT |
| Oct 12, 1990 | K903691 | A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX. Therex Corp. | LJT |
| Oct 10, 1990 | K903220 | PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM Pharmacia Deltec, Inc. | LJT |
| Sep 5, 1990 | K901419 | DUAL PORT Infusaid Corp. | LJT |
| Jul 3, 1990 | K901722 | CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM Device Labs, Inc. | LJT |
| Apr 17, 1990 | K895030 | LIFE-LINE(TM) VASCULAR ACCESS SYSTEM Medical Engineering and Development Institute | LJT |
| Mar 12, 1990 | K894650 | Q-PORT SYSTEM KIT Quinton, Inc. | LJT |
| Dec 27, 1989 | K895689 | LIFEPORT VASCULAR ACCESS PORT Strato Medical Corp. | LJT |
| Dec 6, 1989 | K896093 | A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT Therex Corp. | LJT |
| Nov 17, 1989 | K895871 | LIFEPORT POLYURETHANE CATHETER Strato Medical Corp. | LJT |
| Jun 23, 1989 | K893460 | A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM Therex Corp. | LJT |
| Jun 12, 1989 | K891611 | MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH. Medtronic Versaflex, Inc. | LJT |
| Apr 21, 1989 | K890518 | SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM Harbor Medical Devices, Inc. | LJT |
| Aug 9, 1988 | K881342 | IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM Burron Medical, Inc. | LJT |
| Jul 29, 1988 | K882230 | A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED Therex Corp. | LJT |
| Jun 9, 1988 | K882190 | S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM Harbor Medical Devices, Inc. | LJT |
| Jun 3, 1988 | K881075 | LIFEPORT II, MODEL LPS-1100 Strato Medical Corp. | LJT |
| May 11, 1988 | K881745 | INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER Shiley Infusaid, Inc. | LJT |
| Apr 26, 1988 | K880305 | LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH. Strato Medical Corp. | LJT |
| Apr 21, 1988 | K881256 | NON CORING INFUSION SET Taris Corp. | LJT |
| Apr 13, 1988 | K875276 | PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM Pharmacia Deltec, Inc. | LJT |
| Mar 4, 1988 | K880571 | CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM Catheter Technology Corp. | LJT |
| Mar 3, 1988 | K875213 | SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE Titan Medical, Inc. | LJT |
| Feb 19, 1988 | K880297 | SEA - PORT INFUSION SET Harbor Medical Devices, Inc. | LJT |
| Feb 19, 1988 | K875214 | A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM Therex Corp. | LJT |
| Dec 30, 1987 | K874184 | CHEMO-PORT Hdc Corp. | LJT |
| Nov 13, 1987 | K873575 | UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90 Healthcare Technologies, Inc. | LJT |
| Nov 13, 1987 | K872329 | INFUSE-A-PORT ADDITIONAL SIZES Shiley Infusaid, Inc. | LJT |
| Nov 3, 1987 | K873735 | MEDTRONIC CATHETER ACCESS PORT MODEL 8500 Medtronic Vascular | LJT |
| Oct 27, 1987 | K873213 | HICKMAN PLASTIC SUBCUTANEOUS PORT C.R. Bard, Inc. | LJT |
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