510(k) K942024 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
| Applicant | Pharmacia Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jul 26, 1994 |
| Received | Apr 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942024
| 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 T2 Fluoro-Free, Venous Access System, PolyFlow Pol Terminated |
MMP | None listed |
| 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 T2 Fluoro-Free, Venous Access System, PolyFlow Pol Terminated |
MMP | None listed |
| 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 II Fluoro-Free, Low Profile Venous Access System, PolyFlow Poly 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 T2 Fluoro-Free, Venous Access System, PolyFlow Po 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 T2 Fluoro-Free, Venous Access System, PolyFlow Po 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 II Fluoro-Free, Low Profile Venous Access System, PolyFlow Po 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 II Fluoro-Free, Low Profile Venous Access System, PolyFlow Po Terminated |
MMP | None listed |
| Jan 28, 2005 | Smiths Medical MD, Inc. Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6 mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introdu Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.