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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 K122854
Device Name ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
Applicant
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact JULIE LAWSON
Correspondent
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact JULIE LAWSON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/18/2012
Decision Date 01/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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