510(k) K211738 ยท MCW Catheter, Peripheral, Atherectomy
Rotarex Atherectomy System
| Applicant | C.R. Bard, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Sep 14, 2021 |
| Received | Jun 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2025 | Bard Peripheral Vascular Inc Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:
S 6 F x 110 cm, REF: 80236;
S 6 F x 135 cm, REF: 80237;
S 8 F x 85 cm, REF: 80238;
S 8 F x 110 cm, REF: 80239 Open, Classified |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.