Clearance Summary
AB CARDIETTE START 200 HV received FDA 510(k) clearance under submission number K010822, sponsored by H&C Medical Devices Spa. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-04-18.
- Submission: K010822
- Applicant / Sponsor: H&C Medical Devices Spa
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2001-04-18
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.