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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 K885154
Device Name INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM
Applicant
Medtronic Blood Systems, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Applicant Contact SHARON ROCKWELL
Correspondent
Medtronic Blood Systems, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent Contact SHARON ROCKWELL
Regulation Number870.4280
Classification Product Code
KRJ  
Date Received12/15/1988
Decision Date 02/22/1989
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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