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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K241784
Device Name Arrow® Nitinol Wire
Applicant
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Madison Snyder
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Madison Snyder
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/20/2024
Decision Date 09/18/2024
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
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