510(k) K973862 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
| Applicant | Sims Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Dec 29, 1997 |
| Received | Oct 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973862
| 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 Low Profile Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4035-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Low Profile Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4037-24 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.