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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K261950
Device Name Health Line Tearaway Introducer
Applicant
Health Line International Corporation
260 N. Ace Yeager Ct., Unit D
Salt Lake City,  UT  84116
Applicant Contact Aaron Faulkner
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/10/2026
Decision Date 06/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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