Turbo-Power Laser Atherectomy Catheter
FDA 510(k) clearance K152181 · decided 2015-11-12
Clearance details
- K-number
- K152181
- Device name
- Turbo-Power Laser Atherectomy Catheter
- Applicant
- Spectranetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-04
- Decision date
- 2015-11-12
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Colorado Springs, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Lase recall (Z-0758-2016) | Spectranetics Corp. | 2016-02-05 |