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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 K241637
Device Name Echo Intracranial Base Catheter
Applicant
Stryker Neurovascular
47900 Bayside Pkwy
Fremont,  CA  94538
Applicant Contact Shameena Segui
Correspondent
Stryker Neurovascular
47900 Bayside Pkwy
Fremont,  CA  94538
Correspondent Contact Shameena Segui
Regulation Number870.1250
Classification Product Code
QJP  
Date Received06/07/2024
Decision Date 12/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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