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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 K210635
FOIA Releasable 510(k) K210635
Device Name Route 92 Medical Full Length 088 Access System
Applicant
Route 92 Medical Inc.
155 Bovet Road, Suite 100
San Mateo,  CA  94402
Applicant Contact Kirsten Valley
Correspondent
Route 92 Medical Inc.
155 Bovet Road, Suite 100
San Mateo,  CA  94402
Correspondent Contact Kirsten Valley
Regulation Number870.1250
Classification Product Code
QJP  
Date Received03/03/2021
Decision Date 07/27/2021
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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