OptiCross™ 18 Peripheral Imaging Catheter
FDA 510(k) clearance K222568 · decided 2022-09-23
Clearance details
- K-number
- K222568
- Device name
- OptiCross™ 18 Peripheral Imaging Catheter
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-08-24
- Decision date
- 2022-09-23
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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No recalls on record reference this clearance.
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