Clearance Summary
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER received FDA 510(k) clearance under submission number K010099, sponsored by Zcv ,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 2001-02-01.
- Submission: K010099
- Applicant / Sponsor: Zcv ,Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 2001-02-01
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.