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FDA 510(k) Applications Submitted by Route 92 Medical, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K203043
10/06/2020
Route 92 Medical 070 Access System
Route 92 Medical, Inc.
K180201
01/24/2018
Route 92 Medical Access System
Route 92 Medical, Inc.
K231583
05/31/2023
Route 92 Medical Full Length 054 Access System
Route 92 Medical, Inc.
K222743
09/09/2022
Route 92 Medical Full Length 070 Access System
Route 92 Medical, Inc.
K223530
11/23/2022
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Route 92 Medical, Inc.
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