510(k) K081425 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
| Applicant | Cook Vascular, Inc., Vandergrift PA, US |
| Decision | Substantially Equivalent, Sep 30, 2008 |
| Received | May 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2017 | Cook Vascular Inc. Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S,
Product usage: The devices are intended for use in patient therapy requiring long-ter Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.