# K063844: Reprocessed Heart Stabilizers and Positioners

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Mar 15, 2007 after 79 days
- Product code: NQG (Stabilizer, Heart, Non-Compression, Reprocessed)
- Device class: 1
- Regulation: 21 CFR 870.4500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964445 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964445: Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006), Dlp, Inc. (1997) Summary page 1.

## Indications for use
Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during off-pump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.

Source page: https://510kreport.com/device/K063844
Methodology: https://510kreport.com/methodology