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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 K052205
Device Name CAPIOX AF125X ARTERIAL FILTER
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact GARRY A COURTNEY
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact GARRY A COURTNEY
Regulation Number870.4260
Classification Product Code
DTM  
Date Received08/12/2005
Decision Date 09/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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