| 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 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 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 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 228956 | 1993163759 | P170027 | TherOx Downstream System | MWG | 2019-04-02 |
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, 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...
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