510(k) K871132 ยท DYB Introducer, Catheter
PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS
| Applicant | Deltec Systems, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 20, 1987 |
| Received | Mar 20, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2013 | Smiths Medical ASD, Inc. Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only
PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to p Terminated |
DYB | 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 II Fluoro-Free, Venous Access System, PolyFlow Polyurethane C 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, Venous Access System, PolyFlow Polyurethane C 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 Dual-lumen Fluoro-Free Venous Access System, Dual Lumen Si Terminated |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.