Medical Device Manufacturer · US , Austin , TX

Origen Biomedical, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2001

Recent clearances: ORIGEN REINFORCED DUAL LUMEN CATHETER, CRYOBAG, MODEL CB, ORIGEN DUAL LUMEN CATHETER

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Jul 26, 2012

ORIGEN REINFORCED DUAL LUMEN CATHETER

Cardiovascular · 209d

Cleared Jun 08, 2001

ORIGEN DUAL LUMEN CATHETER

Cardiovascular · 231d

Cleared Apr 20, 2001

ORIGEN BLADDER HOLDER

Cardiovascular · 192d