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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 K223530
Device Name Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
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
NRY  
Date Received11/23/2022
Decision Date 04/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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