CorVista® System
FDA 510(k) clearance K232686 · decided 2023-09-08
Clearance details
- K-number
- K232686
- Device name
- CorVista® System
- Applicant
- Corvista Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-01
- Decision date
- 2023-09-08
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- QXX
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.