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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 K010330
Device Name ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
Applicant
Arrow Intl., Inc.
9 Plymouth St.
Everett,  MA  02149
Applicant Contact WILLIAM PAQUIN
Correspondent
Arrow Intl., Inc.
9 Plymouth St.
Everett,  MA  02149
Correspondent Contact WILLIAM PAQUIN
Regulation Number870.3535
Classification Product Code
DSP  
Date Received02/02/2001
Decision Date 03/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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