510(k) K925373 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D
| Applicant | Therex Corp., Walpole MA, US |
| Decision | Substantially Equivalent, May 6, 1993 |
| Received | Oct 23, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925373
| 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-06016. Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.