510(k) K072657 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS
| Applicant | Smiths Medical MD, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Dec 14, 2007 |
| Received | Sep 20, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072657
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2020 | Smiths Medical ASD Inc. PORT-A-CATH II POWER P.A.C. Low Profile" system. Terminated |
LJT | None listed |
| Jul 8, 2019 | Smiths Medical ASD Inc. GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions:
1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA;
2. TRAY, PAC, VEN LP, T Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.