Route 92 Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Route 92 Medical Full Length 046 Access System, Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, 8F Modified Sheath System
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Route 92 Medical, Inc. Neurology ✕
13 devices
Cleared
Sep 16, 2026
Route 92 Medical Full Length 046 Access System
Neurology
233d
Cleared
CT
May 19, 2025
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
Neurology
179d
Cleared
Oct 02, 2024
8F Modified Sheath System
Neurology
222d
Cleared
Apr 23, 2024
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
Neurology
207d
Cleared
Aug 15, 2023
Route 92 Medical Full Length 054 Access System
Neurology
76d
Cleared
Apr 11, 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Neurology
139d
Cleared
Oct 04, 2022
Route 92 Medical Full Length 070 Access System
Neurology
25d
Cleared
Jul 27, 2021
Route 92 Medical Full Length 088 Access System
Neurology
146d
Cleared
Nov 11, 2020
Route 92 Medical 070 Access System
Neurology
36d
Cleared
Apr 18, 2020
Route 92 Medical 088 Access System, 110 cm
Neurology
88d
Cleared
Jan 13, 2020
Route 92 Medical Sheath System
Neurology
201d
Cleared
Mar 21, 2019
Route 92 Medical Delivery Catheter
Neurology
27d