Spectranetics Turbo-Elite Laser Atherectomy Catheters
FDA 510(k) clearance K170059 · decided 2017-04-07
Clearance details
- K-number
- K170059
- Device name
- Spectranetics Turbo-Elite Laser Atherectomy Catheters
- Applicant
- Spectranetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-06
- Decision date
- 2017-04-07
- Days to decision
- 91 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 |
|---|---|---|
| Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 41 recall (Z-0680-2025) | Spectranetics Corporation | 2024-12-16 |
| Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turb recall (Z-0509-2024) | Spectranetics Corporation | 2023-12-08 |
| Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters D recall (Z-2863-2017) | Spectranetics Corporation | 2017-07-14 |