510(k) K203363 ยท PDU Catheter For Crossing Total Occlusions
Crosser iQ CTO Recanalization System
| Applicant | C.R. Bard, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Aug 12, 2021 |
| Received | Nov 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Bard Peripheral Vascular Inc BD Recanalization System, REF: BDRECANSYSTEM Open, Classified |
PDU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.