TurboHawk Plus Directional Atherectomy System
FDA 510(k) clearance K212027 · decided 2021-08-24
Clearance details
- K-number
- K212027
- Device name
- TurboHawk Plus Directional Atherectomy System
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-29
- Decision date
- 2021-08-24
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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