The following data is part of a premarket notification filed by Sulzer Carbomedics, Inc. with the FDA for Annuloflo System, Mitral Model Ar700.
| Device ID | K021051 |
| 510k Number | K021051 |
| Device Name: | ANNULOFLO SYSTEM, MITRAL MODEL AR700 |
| Classification | Ring, Annuloplasty |
| Applicant | SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Teffany Hankinson |
| Correspondent | Teffany Hankinson SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08022057013712 | K021051 | 000 |
| 08022057013705 | K021051 | 000 |
| 08022057013699 | K021051 | 000 |
| 08022057013682 | K021051 | 000 |
| 08022057013675 | K021051 | 000 |
| 08022057013668 | K021051 | 000 |