Comet II Pressure Guidewire
FDA 510(k) clearance K193279 · decided 2019-12-23
Clearance details
- K-number
- K193279
- Device name
- Comet II Pressure Guidewire
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-11-27
- Decision date
- 2019-12-23
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- DXO
- Device class
- 2
- Regulation number
- 870.2870
- 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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