The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Carpentier-mccarthy-adams Imr Etlogix Annuloplasty Ring, Model 4100.
| Device ID | K083623 |
| 510k Number | K083623 |
| Device Name: | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 |
| 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 | 2008-12-08 |
| Decision Date | 2009-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103163155 | K083623 | 000 |
| 00690103163148 | K083623 | 000 |
| 00690103163131 | K083623 | 000 |
| 00690103163124 | K083623 | 000 |
| 00690103163117 | K083623 | 000 |
| 00690103163100 | K083623 | 000 |