ROTAPRO Rotational Atherectomy System
FDA 510(k) clearance K220962 · decided 2022-09-06
Clearance details
- K-number
- K220962
- Device name
- ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-04-01
- Decision date
- 2022-09-06
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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