The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Seguin Annuloplasty Ring.
| Device ID | K092310 |
| 510k Number | K092310 |
| Device Name: | SEGUIN ANNULOPLASTY RING |
| Classification | Ring, Annuloplasty |
| Applicant | ST. JUDE MEDICAL 177 EAST COUNTY ROAD B St. Paul, MN 55117 |
| Contact | Thomas Rademacher |
| Correspondent | Thomas Rademacher ST. JUDE MEDICAL 177 EAST COUNTY ROAD B St. Paul, MN 55117 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2009-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734007566 | K092310 | 000 |
| 05415067044815 | K092310 | 000 |
| 05415067044877 | K092310 | 000 |
| 05415067044891 | K092310 | 000 |
| 05415067044754 | K092310 | 000 |
| 05415067044914 | K092310 | 000 |
| 05414734007481 | K092310 | 000 |
| 05414734007498 | K092310 | 000 |
| 05414734007504 | K092310 | 000 |
| 05414734007511 | K092310 | 000 |
| 05414734007528 | K092310 | 000 |
| 05414734007535 | K092310 | 000 |
| 05414734007542 | K092310 | 000 |
| 05414734007559 | K092310 | 000 |
| 05415067044853 | K092310 | 000 |