510(k) K945250 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
TRIMPORT
| Applicant | Gerard Medical Enterprises, Inc., Charlton MA, US |
| Decision | Substantially Equivalent, Mar 7, 1995 |
| Received | Oct 28, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945250
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.