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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 K254236
Device Name Peel-Away Introducer Sheath
Applicant
VascuTech Medical, LLC
98 Highland Ave.
Oaks,  PA  19456
Applicant Contact Katy Feeny
Correspondent
VascuTech Medical, LLC
98 Highland Ave.
Oaks,  PA  19456
Correspondent Contact Katy Feeny
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/29/2025
Decision Date 02/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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