Stabilizer, Heart
A Heart Stabilizer is a mechanical device used during minimally invasive or off-pump coronary artery bypass surgery to immobilize a localized region of the beating heart, enabling surgeons to perform anastomoses on a stable, relatively motionless operative field without the need for cardiopulmonary bypass. It is FDA Class 1, subject to general controls only, with product code MWS under 21 CFR 870.4500 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MWS
- Device Class
- FDA class 1
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K041338 | MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES | Jul 19, 2004 | Substantially Equivalent | Medtronic Vascular |
| K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | Sep 13, 2000 | Substantially Equivalent | Pilling Weck Surgical |
| K992833 | VACUUM ASSIST STABILIZER | Nov 10, 1999 | Substantially Equivalent | Cardio Thoracic Systems |
| K982419 | HEART-LIFT BALLOON POSITIONER | Jan 13, 1999 | Substantially Equivalent | Cardiothoracic Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 42 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.