510(k) K903691 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.
| Applicant | Therex Corp., Walpole MA, US |
| Decision | Substantially Equivalent, Oct 12, 1990 |
| Received | Aug 15, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903691
| 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
Ref Product No. AP-01007. Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.