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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 K260938
Device Name PATH BGC
Applicant
Crossroads Neurovascular, Inc.
105 N. Pt.E Dr., Suite D
Lake Forest,  CA  92630
Applicant Contact Ryan Breckenridge
Correspondent
Crossroads Neurovascular, Inc.
105 N. Pt.E Dr., Suite D
Lake Forest,  CA  92630
Correspondent Contact Ryan Breckenridge
Regulation Number870.1250
Classification Product Code
QJP  
Date Received03/20/2026
Decision Date 04/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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