510(k) K033473 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
| Applicant | Horizon Medical Products, Inc., Manchester GA, US |
| Decision | Substantially Equivalent, Nov 18, 2003 |
| Received | Nov 3, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033473
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2022 | Angiodynamics, Inc. Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requ Open, Classified |
LJT | None listed |
| Aug 24, 2011 | Angiodynamics, INC Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, Inc.,
One Horizon Way,
Manchester, GA 30816
Indicated for central venous placement (either peripheral or c Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.