Clearance Summary
AVIAFIT PULSATING LEGBAND received FDA 510(k) clearance under submission number K071744, sponsored by Flowmedic , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-09-25.
- Submission: K071744
- Applicant / Sponsor: Flowmedic , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2007-09-25
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.