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CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH

K992912 Class II Traditional
Decision Date
2000-03-08
Sponsor / Applicant
Cardiac Pathways Corp.

Technical Specification

510(k) Submission ID K992912
Product Code DRF
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1220
Decision Date 2000-03-08
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH received FDA 510(k) clearance under submission number K992912, sponsored by Cardiac Pathways Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-03-08.

Classification & Regulation

This clearance is catalogued under FDA product code DRF and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.