Clearance Summary
SMI CARDIOVASCULAR PATCH received FDA 510(k) clearance under submission number K122105, sponsored by Solinas Medical, 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 2012-12-07.
- Submission: K122105
- Applicant / Sponsor: Solinas Medical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2012-12-07
Classification & Regulation
This clearance is catalogued under FDA product code DXZ and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.