# K992476: Pilling Weck Surgical Heart Stabilizer Removable Pads

- Pathway: 510(k) (Traditional)
- Applicant: Pilling Weck Surgical
- Decided: Sep 13, 2000 after 415 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.

Source page: https://510kreport.com/device/K992476
Methodology: https://510kreport.com/methodology