Route 92 Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Route 92 Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, 8F Modified Sheath System, Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
13
Total
13
Cleared
0
Denied
Route 92 Medical, Inc. has 13 FDA 510(k) cleared neurology devices. Based in San Mateo, US.
Latest FDA clearance: May 2025. Active since 2018.
Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Route 92 Medical, Inc.
13 devices
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
Cleared
Dec 10, 2018
Route 92 Medical Delivery Catheter
Neurology
89d
Cleared
May 23, 2018
Route 92 Medical Access System
Cardiovascular
119d