510(k) K032557 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
TRIUMPH VTX WITH LIFEVALVE CATHETER
| Applicant | Horizon Medical Products, Inc., Manchester GA, US |
| Decision | Substantially Equivalent, Sep 9, 2003 |
| Received | Aug 19, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2010 | Angiodynamics, INC Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.