510(k) K170059 ยท MCW Catheter, Peripheral, Atherectomy
Spectranetics Turbo-Elite Laser Atherectomy Catheters
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Apr 7, 2017 |
| Received | Jan 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170059
| 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 |
| Dec 8, 2023 | Spectranetics Corporation Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006
Spectranetics Turbo-Elite Laser Atherectomy Catheter Open, Classified |
MCW | None listed |
| Jul 14, 2017 | Spectranetics Corporation Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters
Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.