510(k) K062609 ยท DQY Catheter, Percutaneous
MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
| Applicant | AngioDynamics, Inc., Queensburgy NY, US |
| Decision | Substantially Equivalent, Oct 6, 2006 |
| Received | Sep 5, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062609
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2011 | Angiodynamics Worldwide Headquarters ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbu Terminated |
DQY | None listed |
| Sep 19, 2011 | Angiodynamics Worldwide Headquarters ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801105, BALLOON DIAMETER 5MM, BALLOON LENGTH 4 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbu Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.