510(k) K882230 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED
| Applicant | Therex Corp., Walpole MA, US |
| Decision | Substantially Equivalent, Jul 29, 1988 |
| Received | May 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882230
| 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 Port, 10 Fr. Introducer Kit.
Ref Product No. AP-06520 Terminated |
LJT | None listed |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port.
Ref Product No. AP-01510 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.