THEROX INC.

Matched from indexed company URL: THEROX, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2030964	3000719308	THEROX INC.	1	N	2020-04-25	17500 Cartwright Rd Irvine CA US 92614

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 GUDID	Product	Phone	Email
00862478000407	DownStream System - The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion	949-757-1999	customerservice@therox.com
00862478000414	DownStream System - The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.	949-757-1999	customerservice@therox.com
00862478000421	DownStream Cartridge - The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.	949-757-1999	customerservice@therox.com
00862478000438	SSO2 Catheter - The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.	949-757-1999	customerservice@therox.com
00862478000445	SSO2 Catheter - The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.	949-757-1999	customerservice@therox.com
00862478000452	SSO2 Catheter - The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.	949-757-1999	customerservice@therox.com
00862478000469	SSO2 Catheter - The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.	949-757-1999	customerservice@therox.com
10862478000428	DownStream Cartridge - The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.	949-757-1999	customerservice@therox.com

therox.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
228956	1993163759	P170027	TherOx Downstream System	MWG	2019-04-02

PMA#

TherOx Downstream Console

2022-10-27

TherOx, Inc.17500 Cartwright Rdsuite 100irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS010 Date Received09/30/2022 Decision Date10/27/2022 Product Code MWG Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...

TherOx Downstream System

2022-03-10

TherOx, Inc.17500 Cartwright Rdsuite 100irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS009 Date Received12/17/2021 Decision Date03/10/2022 Product Code MWG Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason C...