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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, balloon, intra-aortic and control
510(k) Number K060309
Device Name AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
Applicant
ARROW INTL., INC.
9 PLYMOUTH ST.
everett,  MA  02149
Applicant Contact karen provencher
Correspondent
ARROW INTL., INC.
9 PLYMOUTH ST.
everett,  MA  02149
Correspondent Contact karen provencher
Regulation Number870.3535
Classification Product Code
DSP  
Date Received02/07/2006
Decision Date 04/06/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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