Clearance Summary
Renew NCP-5 External Counterpulsation System received FDA 510(k) clearance under submission number K152115, sponsored by Stage 2 Innovations. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-12-17.
- Submission: K152115
- Applicant / Sponsor: Stage 2 Innovations
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 2015-12-17
Classification & Regulation
This clearance is catalogued under FDA product code DRN and 21 CFR 870.5225, within the Cardiovascular review panel as a Class II device.