Clearance Summary
CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 received FDA 510(k) clearance under submission number K955551, sponsored by Cardio Metrics, 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 1996-02-28.
- Submission: K955551
- Applicant / Sponsor: Cardio Metrics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 1996-02-28
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.