510(k) K101138 ยท OBJ Catheter, Ultrasound, Intravascular
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Jun 22, 2010 |
| Received | Apr 22, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101138
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.