# K070036: Reprocessed Medtronic Cardiac Stabilization and Positioning Devices

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Aug 17, 2007 after 226 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: 3 generations back to K964445 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041338: Medtronic Octopus TE Stabilizer & Accessories, Medtronic Vascular (2004) Summary page 1.
- K964445: Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006), Dlp, Inc. (1997) Summary page 1.

## Indications for use
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.

Source page: https://510kreport.com/device/K070036
Methodology: https://510kreport.com/methodology