FDA 510(k) Application Details - K241637

Device Classification Name

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510(K) Number K241637
Device Name Echo Intracranial Base Catheter
Applicant Stryker Neurovascular
47900 Bayside Pkwy
Fremont, CA 94538 US
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Contact Shameena Segui
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Regulation Number

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Classification Product Code QJP
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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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