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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K260600
Device Name Neuroguard IEP Embolic Protection System
Applicant
Contego Medical, Inc.
3801 Lake Boone Trl.
Suite 100
Raleigh,  NC  27607
Applicant Contact Nitin Mehta
Correspondent
Contego Medical, Inc.
3801 Lake Boone Trl.
Suite 100
Raleigh,  NC  27607
Correspondent Contact Nitin Mehta
Regulation Number870.1250
Classification Product Code
NTE  
Date Received02/24/2026
Decision Date 11/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT04201132
NCT05845710
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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