510(k) K960572 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
| Applicant | Arrow Intl., Inc., Walpole MA, US |
| Decision | Substantially Equivalent, Apr 26, 1996 |
| Received | Feb 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960572
| 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 B Port, 6 Fr. Introducer Kit.
Ref Product No. AP-06046 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.