The following data is part of a premarket notification filed by Edwards Lifesciences Llc with the FDA for Physio Flex Annuloplasty Ring.
| Device ID | K192762 |
| 510k Number | K192762 |
| Device Name: | Physio Flex Annuloplasty Ring |
| Classification | Ring, Annuloplasty |
| Applicant | Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 |
| Contact | Milinda Mawley |
| Correspondent | Milinda Mawley Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103206241 | K192762 | 000 |
| 00690103206234 | K192762 | 000 |
| 00690103206227 | K192762 | 000 |
| 00690103206210 | K192762 | 000 |
| 00690103206203 | K192762 | 000 |
| 00690103206197 | K192762 | 000 |
| 00690103206180 | K192762 | 000 |
| 00690103206173 | K192762 | 000 |
| 00690103206166 | K192762 | 000 |