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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 K253032
Device Name AXS Lift Intracranial Base Catheter
Applicant
Stryker Neurovascular
47900 Bayside Pkwy.
Freemont,  CA  94538
Applicant Contact Natalie Allen
Correspondent
Stryker Neurovascular
47900 Bayside Pkwy.
Freemont,  CA  94538
Correspondent Contact Natalie Allen
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received09/22/2025
Decision Date 02/11/2026
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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