Route 92 Medical

FDA Filings

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.

FDA Registration(s)

• 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:
  • Kathy Tansey
  • 1-408-3916536-x
• 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:
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00853799007657 ROUTE 92 MEDICAL	FreeClimb 54, 125cm	2023-10-24
GUDID 00853799007640 ROUTE 92 MEDICAL	FreeClimb 54, 148cm	2023-10-24
GUDID 00853799007619 ROUTE 92 MEDICAL	Tenzing 5	2023-10-24
GUDID 00853799007183 ROUTE 92 MEDICAL	FreeClimb 70	2023-05-03
GUDID 00853799007138 ROUTE 92 MEDICAL	Full Length 088 x 132cm Access System REF 4002	2022-06-30
GUDID 00853799007060 ROUTE 92 MEDICAL	Full Length 088 Catheter, 132 cm	2022-06-30
GUDID 00853799007299 ROUTE 92 MEDICAL	Tenzing 8 Delivery Catheter	2021-11-08
GUDID 00853799007282 ROUTE 92 MEDICAL	088 Catheter	2021-11-08
GUDID 00853799007275 ROUTE 92 MEDICAL	088 Access System REF 2004	2021-11-08
GUDID 00853799007404 ROUTE 92 MEDICAL	8F Base Camp Sheath System REF 5001	2020-09-25
GUDID 00853799007237 ROUTE 92 MEDICAL	Tenzing 7 Delivery Catheter REF 1005	2020-09-25
PMN K201518 Route 92 Medical	Route 92 Medical 088 Access System	2020-08-14
PMN K190431 | DQY ROUTE 92 MEDICAL	Tenzing 7 Delivery Catheter	2019-07-11

Similar & Related FDA Registered Companies

• Route 92 Medical Inc.