AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System
FDA 510(k) clearance K152218 · decided 2015-09-21
Clearance details
- K-number
- K152218
- Device name
- AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System
- Applicant
- Osprey Medical
- Decision
- Substantially Equivalent
- Date received
- 2015-08-07
- Decision date
- 2015-09-21
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.