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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Prebypass, Cardiopulmonary Bypass
510(k) Number K884244
Device Name INTERSEPT* PREBYPASS FILTER
Applicant
Medtronic Blood Systems, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent
Medtronic Blood Systems, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Regulation Number870.4280
Classification Product Code
KRJ  
Date Received10/11/1988
Decision Date 12/05/1988
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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