510(k) K092175 ยท PDU Catheter For Crossing Total Occlusions
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
| Applicant | Flowcardia, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 17, 2010 |
| Received | Jul 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092175
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.