# K022363: SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical, Inc.
- Decided: Sep 19, 2002 after 59 days
- Product code: KRH (Ring, Annuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000119 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014161: SJM Tailor Annuloplasty Ring Model Tarp- (Size), St. Jude Medical, Inc. (2002) Summary page 2.

## Indications for use
The SJMB Tailor annuloplasty band is indicated for use in repair of a mitral or tricuspid heart valve that is diseased or damaged due to acquired or congenital processes.

Source page: https://510kreport.com/device/K022363
Methodology: https://510kreport.com/methodology