510(k) K950212 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
A2 DETACHED DUAL PORT SYSTEM
| Applicant | Therex Corp., Walpole MA, US |
| Decision | Substantially Equivalent, Apr 13, 1995 |
| Received | Jan 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950212
| 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, 10 Fr. Introducer Kit
Ref Product No. AP-06530 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.