Physio Flex Annuloplasty Ring
FDA 510(k) clearance K192762 · decided 2019-12-16
Clearance details
- K-number
- K192762
- Device name
- Physio Flex Annuloplasty Ring
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-09-30
- Decision date
- 2019-12-16
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KRH
- Device class
- 2
- Regulation number
- 870.3800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.