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FDA 510(k) Application Details - K241637
Device Classification Name
More FDA Info for this Device
510(K) Number
K241637
Device Name
Echo Intracranial Base Catheter
Applicant
Stryker Neurovascular
47900 Bayside Pkwy
Fremont, CA 94538 US
Other 510(k) Applications for this Company
Contact
Shameena Segui
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/07/2024
Decision Date
12/19/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241637
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