510(k) K072776 ยท PDU Catheter For Crossing Total Occlusions
THE CROSSER SYSTEM
| Applicant | Flowcardia, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Sep 28, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072776
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2011 | Flowcardia Inc. Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA
Intended use: Catheter for use in surgery. Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.