510(k) K897026

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

K897026 is an FDA 510(k) premarket notification submitted by Canyon Medical Products for the device "CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.". The FDA issued a decision of Substantially Equivalent on February 26, 1990. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Canyon Medical Products has at least 2 other 510(k) clearances on record.

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