The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Mc Tricuspid Annuloplasty System, Model 4900.
| Device ID | K020864 |
| 510k Number | K020864 |
| Device Name: | EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 |
| Classification | Ring, Annuloplasty |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Susan Reynolds |
| Correspondent | Susan Reynolds EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-18 |
| Decision Date | 2002-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103182316 | K020864 | 000 |
| 00690103182309 | K020864 | 000 |
| 00690103182293 | K020864 | 000 |
| 00690103182286 | K020864 | 000 |
| 00690103182279 | K020864 | 000 |
| 00690103182262 | K020864 | 000 |