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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 K974155
Device Name BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
Applicant
Baxter Healthcare Corp
17221 Red Hill Ave.
Irvine,  CA  92614
Applicant Contact TOM HUMPHREY
Correspondent
Baxter Healthcare Corp
17221 Red Hill Ave.
Irvine,  CA  92614
Correspondent Contact TOM HUMPHREY
Regulation Number870.4400
Classification Product Code
DTN  
Date Received11/04/1997
Decision Date 01/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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