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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 K252390
Device Name Telescope Guide Extension Catheter
Applicant
Medtronic, Ireland
Parkmore Business Park W.
Galway,  IE H91VY19
Applicant Contact Denise Keehan
Correspondent
Medtronic, Ireland
Parkmore Business Park W.
Galway,  IE H91VY19
Correspondent Contact Denise Keehan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/31/2025
Decision Date 10/29/2025
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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