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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K261772
Device Name Target Xtra Detachable Coil
Applicant
Stryker Neurovscular
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact Zach Borla
Correspondent
Stryker Neurovscular
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact Zach Borla
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received05/29/2026
Decision Date 06/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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