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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K890772
Device Name ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
Applicant
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact ALFRED COUVILLON
Correspondent
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact ALFRED COUVILLON
Regulation Number892.1560
Classification Product Code
IYO  
Date Received02/15/1989
Decision Date 05/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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