510(k) K954258 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)
| Applicant | Gerard Medical Enterprises, Inc., Charlton MA, US |
| Decision | Substantially Equivalent, May 24, 1996 |
| Received | Sep 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954258
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN Product No. M001453030, STERILE, Rx ONLY, For single use only --- Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm), REF Catalog No. 45-305, UPN Product No. M001453050, STERILE, Rx ONLY, For single use only --- Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product No. M001453100, STERILE, Rx ONLY, For single use only --- Im Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-315, UPN Product No. M001453150, STERILE, Rx ONLY, For single use only - Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-320, UPN # - M001453200, STERILE, Rx ONLY, For single use only --- Implant Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-340, UPN Product No. M001453400, STERILE, Rx ONLY, For single use only --- Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN Product No. M001453600, STERILE, Rx ONLY, For single use only - Terminated |
LJT | None listed |
| Apr 14, 2007 | Boston Scientific Corp Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. Boston Scientific ME Terminated |
LJT | None listed |
| Apr 14, 2007 | Boston Scientific Corp Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single Use Only, STERILE, EO, Boston Scientific M Terminated |
LJT | None listed |
| Jan 6, 2006 | Boston Scientific Corporation Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Firm on label: Boston Scientific/Medi-Tech, Watertown, Terminated |
LJS | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Vaxcel Chest Ports - Mini/T/PU/7/1.3/2.2/63
Catalog Number : 45-305 Terminated |
KOB | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Vaxcel Chest Ports - Standard/PS/PU/9/1.8/2.8/63
Catalog Number : 45-360 Terminated |
KOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.