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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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