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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 K233329
Device Name Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
Applicant
Route 92 Medical, Inc.
155 Bovet Rd.
Suite 100
San Mateo,  CA  94402
Applicant Contact Kirsten Valley
Correspondent
Route 92 Medical, Inc.
155 Bovet Rd.
Suite 100
San Mateo,  CA  94402
Correspondent Contact Kirsten Valley
Regulation Number870.1250
Classification Product Code
NRY  
Date Received09/29/2023
Decision Date 04/23/2024
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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