FDA Pre-Market Approval

POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT

FDA Pre-Market Approval

PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20

POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C

FDA 510(k)

FDA Class 2 ·Cardiovascular

POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODELS 1113 AND 1114 PACEMAKER LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

FETCH ASPIRATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO GUARDDOG OCCLUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIVERSAL CORONARY CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO FETCH ASPIRATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039

FDA 510(k)

FDA Class 2 ·Cardiovascular

POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA

FDA 510(k)

FDA Class 3 ·Cardiovascular

FETCH ASPIRATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular