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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 K163513
Device Name Arrow Endurance Extended Dwell Peripheral Catheter System
Applicant
Arrow International, Inc. (subsidiary of Teleflex Inc.)
2400 Bernville Road
Reading,  PA  19605
Applicant Contact Fallon Young
Correspondent
Arrow International, Inc. (subsidiary of Teleflex Inc.)
2400 Bernville Road
Reading,  PA  19605
Correspondent Contact Fallon Young
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/15/2016
Decision Date 02/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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