510(k) K974471 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A
| Applicant | Sims Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jan 22, 1998 |
| Received | Nov 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2018 | Smiths Medical ASD Inc. PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as:
a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA);
b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA);
c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 2.2mm O.D. x 1.0mm I.D., 7 French Introducer Set, REF 21-8066-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 3.2mm O.D. x 1.4mm I.D., 10 French Introducer Set, REF 21-8068-24 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.