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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 K940079
Device Name ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
Applicant
ARROW INTL., INC.
3000 BERNVILLE RD.
READING,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
3000 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact THOMAS D NICKEL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/07/1994
Decision Date 11/30/1994
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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