Medical Device Manufacturer · US , Irvine , CA

Therox, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1997

Recent clearances: THEROX INFUSION CATHETER, MODEL INCA-1, THEROX INFUSION GUIDEWIRES

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Therox, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Mar 08, 2006

THEROX INFUSION CATHETER, MODEL INCA-1

Cardiovascular · 163d

Cleared Nov 03, 1997

THEROX INFUSION GUIDEWIRES

Cardiovascular · 178d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 07, 2026