510(k) K091352 ยท OBJ Catheter, Ultrasound, Intravascular
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Dec 4, 2009 |
| Received | May 7, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091352
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.