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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 K896338
Device Name VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA
Applicant
Voss Medical Products
4227 Centergate
San Antonio,  TX  78217
Applicant Contact STEVE HOLLOWAY
Correspondent
Voss Medical Products
4227 Centergate
San Antonio,  TX  78217
Correspondent Contact STEVE HOLLOWAY
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/03/1989
Decision Date 05/17/1990
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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