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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 K000729
Device Name ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
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 Received03/06/2000
Decision Date 05/19/2000
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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