Compass Cast and MAP
FDA 510(k) clearance K161408 · decided 2016-11-22
Clearance details
- K-number
- K161408
- Device name
- Compass Cast and MAP
- Applicant
- Centurion Medical Products Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-05-20
- Decision date
- 2016-11-22
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Williamston, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.