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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K780532
Device Name PERCUTANEOUS SHEATH INTRODUCER KIT
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 Number870.1340
Classification Product Code
DYB  
Date Received04/04/1978
Decision Date 04/21/1978
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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