Panels › Cardiovascular › Product code MWS · Class 1
Stabilizer, Heart
Regulation 870.4500
0510(k)s in 12 months (4 all time)
4recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in MWS
| Company | 510(k)s | Recalls |
|---|---|---|
| Maquet Cardiovascular, LLC | 0 | 8 |
| Medtronic Perfusion Systems | 0 | 4 |
| Terumo Cardiovascular Systems Corporation | 0 | 3 |
| Guidant Cardiac Surgery | 0 | 2 |
| Cardio Thoracic Systems | 1 | 0 |
| Cardiothoracic Systems, Inc. | 1 | 0 |
| Medtronic Vascular | 1 | 0 |
| Pilling Weck Surgical | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 2004 | K041338 | MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES Medtronic Vascular | MWS |
| Sep 13, 2000 | K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS Pilling Weck Surgical | MWS |
| Nov 10, 1999 | K992833 | VACUUM ASSIST STABILIZER Cardio Thoracic Systems | MWS |
| Jan 13, 1999 | K982419 | HEART-LIFT BALLOON POSITIONER Cardiothoracic Systems, Inc. | MWS |
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