Clearance Summary
8F FlowGate2 Balloon Guide Catheter received FDA 510(k) clearance under submission number K153729, sponsored by Concentric Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-01-27.
- Submission: K153729
- Applicant / Sponsor: Concentric Medical
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2016-01-27
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.