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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K936232
Device Name BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
Applicant
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Applicant Contact PAMELA L CADORETTE
Correspondent
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Correspondent Contact PAMELA L CADORETTE
Regulation Number870.3535
Classification Product Code
DSP  
Date Received12/29/1993
Decision Date 10/14/1994
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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