510(k) K934792 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
THEREX LOW-PROFILE PORT
| Applicant | Therex Corp., Walpole MA, US |
| Decision | Substantially Equivalent, Mar 22, 1994 |
| Received | Oct 6, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934792
| 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. 6 Fr. Introducer Kit
Ref. Product No. AP-06036 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.