SATURATION/HEMATOCRIT MONITOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERSEPT* PREBYPASS FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOSED CHEST SUPPORT CIRCUIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MVR COLLAPSIBLE VENOUS RESERVOIR BAG

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAXIMA FORTE HARDSHELL VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAXIMA PLUS HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERSEPT FILTERED CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0

FDA 510(k)

FDA Class 2 ·Cardiovascular

MCR4000 & MCR4000F CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

EASI LEAD SYSTEM CABLE ASSEMBLY

FDA 510(k)

FDA Class 2 ·Cardiovascular

PCX-100 PATIENT INPUT LEADWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEPARIN COATED STAINLESS STEEL/TEFLON

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EASI ECG ALGORITHM

FDA 510(k)

FDA Class 2 ·Cardiovascular