The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Carpentier-edwards Physio Tricuspid Annuloplasty Ring.
| Device ID | K103520 |
| 510k Number | K103520 |
| Device Name: | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING |
| Classification | Ring, Annuloplasty |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Daryl Richardson |
| Correspondent | Daryl Richardson 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 | 2010-11-30 |
| Decision Date | 2011-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103188486 | K103520 | 000 |
| 00690103188479 | K103520 | 000 |
| 00690103188462 | K103520 | 000 |
| 00690103188455 | K103520 | 000 |
| 00690103188448 | K103520 | 000 |
| 00690103188431 | K103520 | 000 |
| 00690103188424 | K103520 | 000 |