The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Carpentier- Edwards Physio Ii Annuloplasty, Model 5200.
| Device ID | K083470 |
| 510k Number | K083470 |
| Device Name: | CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 |
| Classification | Ring, Annuloplasty |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Erica Walters |
| Correspondent | Erica Walters 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 | 2008-11-24 |
| Decision Date | 2009-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103180251 | K083470 | 000 |
| 00690103180244 | K083470 | 000 |
| 00690103180237 | K083470 | 000 |
| 00690103180220 | K083470 | 000 |
| 00690103180213 | K083470 | 000 |
| 00690103180206 | K083470 | 000 |
| 00690103180183 | K083470 | 000 |
| 00690103180176 | K083470 | 000 |
| 00690103180190 | K083470 | 000 |