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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K872472
Device Name SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE
Applicant
Angiomedics, Inc.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact HOWARD B WITTELS
Correspondent
Angiomedics, Inc.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact HOWARD B WITTELS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received06/23/1987
Decision Date 09/14/1987
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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