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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K810675
Device Name ARROW RADIAL ARTERY CATHETERIZATION SET
Applicant
ARROW INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ARROW INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/12/1981
Decision Date 03/27/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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