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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K897026
Device Name CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.
Applicant
Canyon Medical Products
3706 W. 2100 S.
Salt Lake City,  UT  84120
Applicant Contact STEVEN M SMITH
Correspondent
Canyon Medical Products
3706 W. 2100 S.
Salt Lake City,  UT  84120
Correspondent Contact STEVEN M SMITH
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/19/1989
Decision Date 02/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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