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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K151513
Device Name Arrow Endurance Extended Dwell Peripheral Catheter System
Applicant
Arrow Internation, Inc. (subsidiary of Teleflex Inc.)
2400 Bernville Rd
Reading,  PA  19605
Applicant Contact Tracy Larish
Correspondent
THIRD PARTY REVIEW GROUP, LLC
45 ROCKEFELLER PLAZA
SUITE 2000
NEW YORK,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/04/2015
Decision Date 07/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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