# K982419: Heart-Lift Balloon Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Cardiothoracic Systems, Inc.
- Decided: Jan 13, 1999 after 184 days
- Product code: MWS (Stabilizer, Heart)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Baxter Janke-Barron Heart Support: named in the summary without a submission number

## Most influential descendants
- K070034: Reprocessed Guidant Cardiac Stabilization and Positioning Devices (2007), 0 descendants of its own

## Indications for use
The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.

Source page: https://510kreport.com/device/K982419
Methodology: https://510kreport.com/methodology