510(k) K897026

CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO. by Canyon Medical Products — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
December 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type