Clearance Summary
STEALTH 360 ORBITAL PAD SYSTEM received FDA 510(k) clearance under submission number K131092, sponsored by Cardio Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-06-24.
- Submission: K131092
- Applicant / Sponsor: Cardio Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 2013-06-24
Classification & Regulation
This clearance is catalogued under FDA product code MCW and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.