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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Angioscope
510(k) Number K931464
Device Name BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
Applicant
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. Box 11150
Irvine,  CA  92614
Applicant Contact CORINA HEMPFLING
Correspondent
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. Box 11150
Irvine,  CA  92614
Correspondent Contact CORINA HEMPFLING
Regulation Number876.1500
Classification Product Code
LYK  
Date Received03/24/1993
Decision Date 10/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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