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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K760387
Device Name CATHETER, CAVA (CAVAFIX)
Applicant
B. BRAUN INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
B. BRAUN INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/05/1976
Decision Date 11/02/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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