FDA.reportPublic FDA data

ROUTE 92 MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
008537990077018F Base Camp system 2.0 80cm - Gen 2.0650-350-9416Customerservice@r92m.com
008537990077188F Base Camp system 2.0 80cm - 8F Base Camp system 2.0 80cm: Contains 8F Base Camp system 2.0 80cm (00853799007701)650-350-9416Customerservice@r92m.com
008537990077258F Base Camp system 2.0 90cm - Gen 2.0650-350-9416Customerservice@r92m.com
008537990077328F Base Camp system 2.0 90cm - 8F Base Camp System 2.0 90cm: Contains 8F Base Camp System 2.0 90cm (00853799007930)650-350-9416Customerservice@r92m.com
00853799007749FreeClimb 88 catheter, 125cm - Gen 1650-350-9416Customerservice@r92m.com
00853799007756FreeClimb 88 catheter, 132cm - Gen 1650-350-9416Customerservice@r92m.com
00853799007763FreeClimb 88 catheter, 125cm with Tenzing 8 - FreeClimb 88 catheter, 125cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 125cm (00853799007749)650-350-9416Customerservice@r92m.com
008537990079308F Base Camp System 2.0 90cm - Gen 2.0650-350-9416Customerservice@r92m.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
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
DQY22019-03-21

PMN#

GUDID#