510(k) K093414 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
| Applicant | Smiths Medical Asd, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Mar 1, 2010 |
| Received | Nov 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2018 | Smiths Medical ASD Inc. Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as:
a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA);
b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA);
c. VEN LP, PU, 1.9MM, UL, 6 FR/IN Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.