510(k) K942412 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
THEREX LOW-PROFILE PORT - TITANIUM MODEL
| Applicant | Therex Corp., Walpole MA, US |
| Decision | Substantially Equivalent, Aug 19, 1994 |
| Received | May 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942412
| 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 Low Profile Port. 9 Fr. Introducer Kit.
Ref Product No. AP -06040 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.