Medical Device Manufacturer · US , Austin , TX

Jostra Bentley - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1995

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Jostra Bentley Cardiovascular ✕

3 devices

1-3 of 3

Cleared Sep 20, 1999

HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010

Cardiovascular · 52d

Cleared Aug 19, 1999

JOSTRA HL-20 TWIN PUMP

Cardiovascular · 259d

Cleared Mar 29, 1995

JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE...

Cardiovascular · 128d