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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K952270
Device Name DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN
Applicant
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92713
Applicant Contact SHARON THOMPSON
Correspondent
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92713
Correspondent Contact SHARON THOMPSON
Regulation Number870.4260
Classification Product Code
DTM  
Date Received05/15/1995
Decision Date 08/21/1995
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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