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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 K200121
Device Name Route 92 Medical 088 Access System, 110 cm
Applicant
Route 92 Medical, Inc.
1700 S. El Camino Real Suite 206
San Mateo,  CA  94402
Applicant Contact Kathy Tansey
Correspondent
Route 92 Medical, Inc.
1700 S. El Camino Real Suite 206
San Mateo,  CA  94402
Correspondent Contact Kathy Tansey
Regulation Number870.1250
Classification Product Code
QJP  
Date Received01/21/2020
Decision Date 04/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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