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SSO2 Catheter

FDA UDI

Class III (US FDA UDI)

by Therox, Inc.

Identity

Trade Name
SSO2 Catheter FDA UDI
Generic Name
Supersaturated oxygen therapy system catheter FDA UDI
Device Name
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. FDA UDI
Model / Reference
SSO2 - 4.0 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00862478000438 FDA UDI
PMA Number
P170027 FDA UDI
FDA Product Code
MWG FDA UDI
GMDN Term
Supersaturated oxygen therapy system catheter FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Supersaturated oxygen therapy system catheter

SSO2 Catheter by Therox, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Supersaturated oxygen therapy system catheter.

Cleared under the same submission

P170027 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Therox, Inc.

Sources (1)

  • FDA UDI f94d0120-43da-4a8c-a475-ed8535ef4711 36 fields · synced May 31, 2026