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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
510(k) Number K191717
Device Name Route 92 Medical Sheath System
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
DQY  
Date Received06/26/2019
Decision Date 01/13/2020
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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