510(k) K161208 ยท PDU Catheter For Crossing Total Occlusions
CROSSER CTO Recanalization Catheter
| Applicant | Bard Peripheral Vacular, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, May 24, 2016 |
| Received | Apr 28, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161208
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.