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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, continuous flush
510(k) Number K896819
Device Name VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Applicant Contact M TAFLINGER
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Correspondent Contact M TAFLINGER
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/04/1989
Decision Date 01/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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