510(k) K172315 ยท MCW Catheter, Peripheral, Atherectomy
Straub Endovascular System
| Applicant | Straub Medical AG, Wangs, CH |
| Decision | Substantially Equivalent, Apr 12, 2018 |
| Received | Aug 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172315
| 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.