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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 K252227
Device Name Pounce(TM) Sheath
Applicant
Surmodics,Inc.
7905 Golden Triangle Dr.
Eden Prairie,  MN  55443
Applicant Contact Peter Bather
Correspondent
Surmodics,Inc.
7905 Golden Triangle Dr.
Eden Prairie,  MN  55443
Correspondent Contact Peter Bather
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/16/2025
Decision Date 09/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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