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ROUTE 92 MEDICAL INC

FDA Regulatory Profile

Summary

Total Recalls
5 (5 Class I)
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1611-2024Class IRoute 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for IntroduMarch 8, 2024
Z-1613-2024Class IRoute 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction March 8, 2024
Z-1614-2024Class IRoute 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of inteMarch 8, 2024
Z-1610-2024Class IRoute 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction oMarch 8, 2024
Z-1612-2024Class IRoute 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of intervMarch 8, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetMay 19, 2025
K2405298F Modified Sheath SystemOctober 2, 2024
K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetApril 23, 2024
K231583Route 92 Medical Full Length 054 Access SystemAugust 15, 2023
K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetApril 11, 2023
K222743Route 92 Medical Full Length 070 Access SystemOctober 4, 2022
K210635Route 92 Medical Full Length 088 Access SystemJuly 27, 2021
K203043Route 92 Medical 070 Access SystemNovember 11, 2020
K201518Route 92 Medical 088 Access SystemAugust 14, 2020
K200121Route 92 Medical 088 Access System, 110 cmApril 18, 2020
K191717Route 92 Medical Sheath SystemJanuary 13, 2020
K190431Route 92 Medical Delivery CatheterMarch 21, 2019
K182512Route 92 Medical Delivery CatheterDecember 10, 2018
K180201Route 92 Medical Access SystemMay 23, 2018