Opticross 35 15 MHz Peripheral Imaging Catheter
FDA 510(k) clearance K200733 · decided 2020-04-17
Clearance details
- K-number
- K200733
- Device name
- Opticross 35 15 MHz Peripheral Imaging Catheter
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-03-20
- Decision date
- 2020-04-17
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- 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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