EMBOLX INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3011660785	3011660785	EMBOLX INC.	1	N	2026-01-01	530 Lakeside Dr Ste 150 Sunnyvale CA US 94085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
184524	1213628469	K232536	Soldier Microcatheter	DQO	2024-02-23
184524	2004252207	K180904	Sniper Infusion Catheter with Balloon Occlusion	MJN	2018-06-08
184524	1622744234	K142692	Occlusion Balloon Catheter	MJN	2015-05-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MJN	4	2018-06-08
DQO	1	2024-02-23

PMN#

Soldier Microcatheter
2024-02-23
Embolx, Inc.
Sniper Infusion Catheter With Balloon Occlusion
2018-06-08
Embolx, Inc
Occlusion Balloon Catheter
2015-05-31
EMBOLX, INC.

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.
Embolx, Inc.
2026-05-20
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.
Embolx, Inc.
2026-05-20
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
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.
Embolx, Inc.
2026-05-20
Sniper® - The Sniper is a dual lumen, 150cm, angled tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-08-29
Sniper® - The Sniper is a dual lumen, 130cm, angled tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-08-29
Sniper® - The Sniper is a dual lumen, 110cm, angled tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-08-29
Sniper - The Sniper is a dual lumen, 110cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-06-22
Sniper - The Sniper is a dual lumen, 130cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-06-22
Sniper - The Sniper is a dual lumen, 150cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-06-22
Sniper - The Sniper is a dual lumen, 150cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-06-22
Sniper - The Sniper is a dual lumen, 130cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-06-22
Sniper - The Sniper is a dual lumen, 110cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2018-06-22
Sniper - Infusion catheter with balloon occlusion
Embolx, Inc.
2017-02-12
Sniper - The Sniper is a dual lumen, 165cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Embolx, Inc.
2022-05-18