510(k) K010189 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
VORTEX ACCESS SYSTEM
| Applicant | Horizon Medical Products, Inc., Manchester GA, US |
| Decision | Substantially Equivalent, Feb 12, 2001 |
| Received | Jan 22, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010189
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2010 | Angiodynamics, INC Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 Terminated |
FRN | None listed |
| Dec 28, 2007 | Rita Medical Systems, Inc. Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.