This page includes the latest FDA filings for Route 92 Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3012725085 |
| FEI Number | 3012725085 |
| Name | ROUTE 92 MEDICAL |
| Owner & Operator | Route 92 Medical |
| Contact Address | 1700 S El Camino Real Suite 206 San Mateo CA 94402 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1700 S El Camino Real Suite 206 San Mateo, CA 94402 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| ROUTE 92 MEDICAL | 8F Base Camp system 2.0 90cm REF 5001-2-90B | 2024-10-22 |
| ROUTE 92 MEDICAL | 8F Base Camp system 2.0 90cm REF 5001-2-90B | 2024-10-22 |
| ROUTE 92 MEDICAL | 8F Base Camp system 2.0 80cm REF 5001-2-80B | 2024-10-22 |
| ROUTE 92 MEDICAL | 8F Base Camp system 2.0 80cm REF 5001-2-80B | 2024-10-22 |
| ROUTE 92 MEDICAL | FreeClimb 88 catheter, 132cm with Tenzing 8 REF 7001-88-132 | 2024-07-09 |
| ROUTE 92 MEDICAL | FreeClimb 88 catheter, 125cm with Tenzing 8 REF 7001-88-125 | 2024-07-09 |
| ROUTE 92 MEDICAL | FreeClimb 88 catheter, 132cm | 2024-07-09 |
| ROUTE 92 MEDICAL | FreeClimb 88 catheter, 125cm | 2024-07-09 |
| ROUTE 92 MEDICAL | FreeClimb 54 reperfusion catheter, 125cm | 2024-07-05 |
| ROUTE 92 MEDICAL | FreeClimb 54 reperfusion catheter, 148cm | 2024-07-05 |
| ROUTE 92 MEDICAL | FreeClimb 54 reperfusion catheter, 125cm with Tenzing 5 REF 7001-54-125R | 2024-06-07 |
| ROUTE 92 MEDICAL | FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5 REF 7001-54-148R | 2024-06-07 |
| ROUTE 92 MEDICAL | 070 Catheter | 2024-05-27 |
| ROUTE 92 MEDICAL | 070 Access System REF 1004 | 2024-05-27 |
| ROUTE 92 MEDICAL | Tenzing 7 Delivery Catheter | 2024-05-24 |
| ROUTE 92 MEDICAL | Tenzing 7 Delivery Catheter REF 1005 | 2024-05-24 |
| ROUTE 92 MEDICAL | FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7 REF 7001-70-132R | 2024-05-24 |
| ROUTE 92 MEDICAL | 8F Base Camp Sheath System REF 5001 | 2024-05-24 |
| ROUTE 92 MEDICAL | 088 x 125 cm Full Length Access System REF 4004 | 2024-05-24 |
| ROUTE 92 MEDICAL | 088 x 125 cm Full Length Catheter | 2024-05-24 |
| ROUTE 92 MEDICAL | FreeClimb 54 x 125 cm Catheter | 2024-05-20 |
| ROUTE 92 MEDICAL | FreeClimb 54 x 148 cm Catheter | 2024-05-20 |
| ROUTE 92 MEDICAL | FreeClimb 54, 125cm | 2023-10-24 |
| ROUTE 92 MEDICAL | FreeClimb 54, 148cm | 2023-10-24 |
| ROUTE 92 MEDICAL | Tenzing 5 | 2023-10-24 |
| ROUTE 92 MEDICAL | FreeClimb 70 | 2023-05-03 |
| ROUTE 92 MEDICAL | Full Length 088 x 132cm Access System REF 4002 | 2022-06-30 |
| ROUTE 92 MEDICAL | Full Length 088 Catheter, 132 cm | 2022-06-30 |
| ROUTE 92 MEDICAL | Tenzing 8 Delivery Catheter | 2021-11-08 |
| ROUTE 92 MEDICAL | 088 Catheter | 2021-11-08 |
| ROUTE 92 MEDICAL | 088 Access System REF 2004 | 2021-11-08 |
| ROUTE 92 MEDICAL | 8F Base Camp Sheath System REF 5001 | 2020-09-25 |
| ROUTE 92 MEDICAL | Tenzing 7 Delivery Catheter REF 1005 | 2020-09-25 |
Route 92 Medical | Route 92 Medical 088 Access System | 2020-08-14 |
ROUTE 92 MEDICAL | Tenzing 7 Delivery Catheter | 2019-07-11 |