Physio Flex Annuloplasty Ring — Edwards Lifesciences, LLC (510(k) K192762)
Physio Flex Annuloplasty Ring — Edwards Lifesciences, LLC (510(k) K192762) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Physio Flex Annuloplasty Ring; Applicant: Edwards Lifesciences, LLC; Clearance track: 510(k).
| Device name | Physio Flex Annuloplasty Ring |
|---|---|
| Applicant | Edwards Lifesciences, LLC |
| Clearance track | 510(k) |
| Submission number | K192762 |
| Decision | Substantially Equivalent |
| Decision date | 2019-12-16 |
| Date received | 2019-09-30 |
| Product code | KRH |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | CA, US |
| Source | openFDA device |
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