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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K243691
Device Name LiquID .051 LP Guide Catheter Extension
Applicant
Seigla Medical, Inc.
7688 5th St. SE
Buffalo,  MN  55313
Applicant Contact Chad Kugler
Correspondent
Seigla Medical, Inc.
7688 5th St. SE
Buffalo,  MN  55313
Correspondent Contact Chad Kugler
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/26/2024
Decision Date 04/04/2025
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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