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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K970049
Device Name BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
Applicant
Cardiovascular Imaging Systems, Inc.
1327 Orleans Dr.
Sunnyvale,  CA  94089 -1136
Applicant Contact STEVE JWANOUSKOS
Correspondent
Cardiovascular Imaging Systems, Inc.
1327 Orleans Dr.
Sunnyvale,  CA  94089 -1136
Correspondent Contact STEVE JWANOUSKOS
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
DQO  
Date Received01/06/1997
Decision Date 06/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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