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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K864895
Device Name INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
Applicant
Johnson & Johnson Professionals, Inc.
P.O. Box 386
King Of Prussia,  PA  19406
Applicant Contact JAMES J BRENNAN
Correspondent
Johnson & Johnson Professionals, Inc.
P.O. Box 386
King Of Prussia,  PA  19406
Correspondent Contact JAMES J BRENNAN
Regulation Number870.4400
Classification Product Code
DTN  
Date Received12/15/1986
Decision Date 02/19/1987
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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