EVERCROSS 0.035 OTW PTA DILATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MPS 3 Myocardial Protection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERVENOUS LEAD INTRODUCER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NMI MICROCATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENROUTE Transcarotid Neuroprotection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOTRONIK PERMANENT PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIOTRONIK DNP UNIPOLAR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZ GOOSE NECK SNARE KIT/ CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

FDA 510(k)

FDA Class 1 ·Cardiovascular

VENA CAVA FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Digital Automatic Blood Pressure Monitor MD2300

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 685/686 DYNAMIC ELECTROCARDI0-

FDA 510(k)

FDA Class 2 ·Cardiovascular

AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMSTAR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Skintact, various other tradenames

FDA 510(k)

FDA Class 3 ·Cardiovascular

ARBO PINK H82P

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIPORE BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2

FDA 510(k)

FDA Class 2 ·Cardiovascular