510(k) K032754 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
VORTEX MP
| Applicant | Horizon Medical Products, Inc., Manchester GA, US |
| Decision | Substantially Equivalent, Sep 12, 2003 |
| Received | Sep 5, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032754
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2011 | Angiodynamics, INC Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter,
AngioDynamics, Inc.,
One Horizon Way,
Manchester, GA 30816
Indicated for central venous placement (either peripheral o Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.