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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, Neurovasculature
510(k) Number K253422
Device Name OAB Delivery Catheter
Applicant
Cognition Medical Corp.
103 Calibre Woods Dr. NE
Atlanta,  GA  30329
Applicant Contact Alex Turjman
Correspondent
Mcra, LLC
803 7th St. NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Robert Herrmann
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received10/01/2025
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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