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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 K242281
Device Name Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)
Applicant
Arrow International, LLC (A Subsidiary of Teleflex, Inc.)
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Kim Pennington
Correspondent
Arrow International, LLC (A Subsidiary of Teleflex, Inc.)
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Kim Pennington
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/02/2024
Decision Date 12/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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