510(k) K091119 ยท PDU Catheter For Crossing Total Occlusions
MODIFICATION TO THE CROSSER SYSTEM
| Applicant | Flowcardia, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 15, 2009 |
| Received | Apr 17, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091119
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.