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Route 92 Medical, Head Quarters

Matched from indexed company URL: Route 92 Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165229673016522967Route 92 Medical, Head Quarters1N2026-01-01155 Bovet Road Suite 100 San Mateo CA US 94402
30300881123030088112Route 92 Medical, West Jordan1N2026-01-011375 W 8040 S W Jordan UT US 84088
30127250853012725085ROUTE 92 MEDICAL1N2020-04-251700 S El Camino Real Suite 206 San Mateo CA US 94402

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00853799007497FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7 - FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7; Contains Tenzing 7 Delivery Catheter (00853799007541) and FreeClimb 70 reperfusion catheter, 132cm (00853799007183)650-350-9416Customerservice@r92m.com
008537990077018F Base Camp system 2.0 80cm - Gen 2.0650-350-9416Customerservice@r92m.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3235261748176692K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetNRY2025-05-19
2607081748176692K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetNRY2025-05-19
2607081327159028K2405298F Modified Sheath SystemQJP2024-10-02
3235261327159028K2405298F Modified Sheath SystemQJP2024-10-02
3235261391391518K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetNRY2024-04-23
2607081391391518K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetNRY2024-04-23
3235261425738130K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetNRY2023-04-11
2607081425738130K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetNRY2023-04-11
2607081088370590K210635Route 92 Medical Full Length 088 Access SystemQJP2021-07-27
3235261088370590K210635Route 92 Medical Full Length 088 Access SystemQJP2021-07-27
2607081361718794K203043Route 92 Medical 070 Access SystemQJP2020-11-11
3235261361718794K203043Route 92 Medical 070 Access SystemQJP2020-11-11
3235261562719885K201518Route 92 Medical 088 Access SystemQJP2020-08-14
2607081562719885K201518Route 92 Medical 088 Access SystemQJP2020-08-14
2607081985257733K191717Route 92 Medical Sheath SystemDQY2020-01-13
3235261985257733K191717Route 92 Medical Sheath SystemDQY2020-01-13
3235261109144460K190431Route 92 Medical Delivery CatheterDQY2019-03-21
2607081109144460K190431Route 92 Medical Delivery CatheterDQY2019-03-21
2079091109144460K190431Route 92 Medical Delivery CatheterDQY2019-03-21
2079091749946116K180201Route 92 Medical Access SystemDQY2018-05-23
2079091981132778

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QJP82024-10-02
NRY62025-05-19
DQY62020-01-13

PMN#

GUDID#