510(k) K992880 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
| Applicant | Sims Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 19, 1999 |
| Received | Aug 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Terminated |
MMP | None listed |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Terminated |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.