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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K263266
Device Name Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
Applicant
Route 92 Medical, Inc.
155 Bovet Rd.
Suite 100
San Mateo,  CA  94402
Applicant Contact Matthew Fortson
Correspondent
Route 92 Medical, Inc.
155 Bovet Road, Suite 100
San Mateo,  CA  94402
Correspondent Contact Matthew Fortson
Regulation Number870.1250
Classification Product Code
NRY  
Date Received09/18/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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