510(k) K911055 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT
| Applicant | Therex Corp., Walpole MA, US |
| Decision | Substantially Equivalent, Apr 19, 1991 |
| Received | Mar 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A(2) Port , 12 Fr. Introducer Kit.
Ref Product Code: AP-06528 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.