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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 K924607
Device Name ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
Applicant
ARROW INTL., INC.
P.O. BOX 12888
3000 BERNVILLE RD
READING,  PA  19612
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
P.O. BOX 12888
3000 BERNVILLE RD
READING,  PA  19612
Correspondent Contact THOMAS D NICKEL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/11/1992
Decision Date 04/22/1993
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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