Clearance Summary
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 received FDA 510(k) clearance under submission number K003118, sponsored by Zcv ,Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-12-20.
- Submission: K003118
- Applicant / Sponsor: Zcv ,Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1240
- Decision date: 2000-12-20
Classification & Regulation
This clearance is catalogued under FDA product code DYG and 21 CFR 870.1240, within the Cardiovascular review panel as a Class II device.