EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BUBBLE-TYPE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBE OXYGENATOR PRODUCTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV

FDA 510(k)

FDA Class 2 ·Cardiovascular

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir

FDA 510(k)

FDA Class 2 ·Cardiovascular

TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I

FDA 510(k)

FDA Class 2 ·Cardiovascular

APEX ADULT HOLLOWE FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

FDA 510(k)

FDA Class 2 ·Cardiovascular