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Route 92 Medical, Head Quarters

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165229673016522967Route 92 Medical, Head Quarters1N2027-01-01155 Bovet Road Suite 100 San Mateo CA US 94402

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2607081452724855K260220Route 92 Medical Full Length 046 Access SystemQJP2026-09-16
2607081748176692K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetNRY2025-05-19
2607081327159028K2405298F Modified Sheath SystemQJP2024-10-02
2607081391391518K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetNRY2024-04-23
2607081425738130K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetNRY2023-04-11
2607081088370590K210635Route 92 Medical Full Length 088 Access SystemQJP2021-07-27
2607081361718794K203043Route 92 Medical 070 Access SystemQJP2020-11-11
2607081562719885K201518Route 92 Medical 088 Access SystemQJP2020-08-14
2607081985257733K191717Route 92 Medical Sheath SystemDQY2020-01-13
2607081109144460K190431Route 92 Medical Delivery CatheterDQY2019-03-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QJP52026-09-16
NRY32025-05-19
DQY22020-01-13