The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Detlogix Annuloplasty Ring, Model: 5100.
| Device ID | K083191 |
| 510k Number | K083191 |
| Device Name: | DETLOGIX ANNULOPLASTY RING, MODEL: 5100 |
| Classification | Ring, Annuloplasty |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Martin A Kaufman |
| Correspondent | Martin A Kaufman 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 | 2008-10-29 |
| Decision Date | 2009-04-10 |
| Summary: | summary |