510(k) K123632 ยท MCW Catheter, Peripheral, Atherectomy
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Jan 25, 2013 |
| Received | Nov 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123632
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2024 | Spectranetics Corporation Turbo Elite Laser Atherectomy Catheter
Model Number / UDI-DI code / Product Description
414-151 / 989930000531 / 1.4 mm OTW
417-152 / 989930000551 / 1.7 mm OTW
420-006 / 989930000571 / 2.0 mm OTW
423- Open, Classified |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.