EMBOLX INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116607853011660785EMBOLX INC.1N2026-01-01530 Lakeside Dr Ste 150 Sunnyvale CA US 94085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1845241213628469K232536Soldier MicrocatheterDQO2024-02-23
1845242004252207K180904Sniper Infusion Catheter with Balloon OcclusionMJN2018-06-08
1845241622744234K142692Occlusion Balloon CatheterMJN2015-05-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MJN42018-06-08
DQO12024-02-23

PMN#

GUDID#

Soldier® - The Soldier High Flow Microcatheter is a single lumen catheter designed to access small, tortuous vasculature. It is available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal tip of the catheter is radiopaque to aid in visualization under fluoroscopy. is a single lumen catheter designed to access small, tortuous vasculature. It is available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal tip of the catheter is radiopaque to aid in visualization under fluoroscopy.

Embolx, Inc.

2026-05-20