The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Sjm Tailor Annuloplasty Band, Model Tab-(size) (tailor Band).
| Device ID | K022363 |
| 510k Number | K022363 |
| Device Name: | SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) |
| Classification | Ring, Annuloplasty |
| Applicant | ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul, MN 55117 |
| Contact | William Mckelvy |
| Correspondent | William Mckelvy ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA 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 | 2002-07-22 |
| Decision Date | 2002-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734055727 | K022363 | 000 |
| 05415067044532 | K022363 | 000 |
| 05415067044556 | K022363 | 000 |
| 05415067044617 | K022363 | 000 |
| 05414734055673 | K022363 | 000 |
| 05414734055680 | K022363 | 000 |
| 05414734055697 | K022363 | 000 |
| 05414734055703 | K022363 | 000 |
| 05414734055710 | K022363 | 000 |
| 05415067044518 | K022363 | 000 |