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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ultrasound, intravascular
510(k) Number K132133
Device Name CG+ ARROW JACC POWERED BY ARROW VPS STYLET
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 Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
LJS  
Date Received07/11/2013
Decision Date 09/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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