MWS · Class I · 21 CFR 870.4500

FDA Product Code MWS: Stabilizer, Heart

Leading manufacturers include Medtronic Vascular, Cardiothoracic Systems, Inc. and Pilling Weck Surgical.

4
Total
4
Cleared
185d
Avg days
1999
Since

FDA 510(k) Cleared Stabilizer, Heart Devices (Product Code MWS)

4 devices
1–4 of 4
Cleared Jul 19, 2004
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
K041338
Medtronic Vascular
Cardiovascular · 60d
Cleared Sep 13, 2000
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
K992476
Pilling Weck Surgical
Cardiovascular · 415d
Cleared Nov 10, 1999
VACUUM ASSIST STABILIZER
K992833
Cardio Thoracic Systems
Cardiovascular · 79d
Cleared Jan 13, 1999
HEART-LIFT BALLOON POSITIONER
K982419
Cardiothoracic Systems, Inc.
Cardiovascular · 184d

About Product Code MWS - Regulatory Context