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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 K254071
Device Name p17 XR Microcatheter
Applicant
Wallaby Medical
22901 Mill Creek Dr.
Laguna Hills,  CA  92653
Applicant Contact Rachel McDaid
Correspondent
Wallaby Medical
22901 Mill Creek Dr.
Laguna Hills,  CA  92653
Correspondent Contact Rachel McDaid
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received12/18/2025
Decision Date 08/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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