Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE A-T 6 FR. SUTURE MEDICATED CLOSURE (SMC) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SUTURE TRIMMER FOR THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF CONTACTR,RF ENHANCR II,RF CONDUCTR,RF MARINR 5F,RF MARINR 7FR

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·THE PERCLOSE A-T (AUTO TIE) SMC DEVICE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·7 FR EZ STEER NAV DS BI-DIRECTIONAL W/ 8MM TIP ELECTRODE W/ DUAL THERMOCOUPLE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF CONTRACTR/RF CONDUCTR/RF MARINR/RF MARINR 5FR/RF ENHANCER II FAMILIES OF ABLATION CATHETERS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CLOSER VASCULAR SEALING SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF CONTACTR, RF CONDUCTR, RF MARINR, RF MARINR 5FR AND RF ENHANCER II FAMILIES OF ABLATION CATHETERS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 AND 610131

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CATH RF CONDUCTR/5 MM 8FR/RF MC 078 6022/CONTACTR CATHETER 7 FR 5MM/RF CONDUCTR MC SELF-REFERENCE CATHETER/RF ENHANCR II

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·X-SITE SUTURE-MEDIATED CLOSURE DEVICE

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Solo Smart Stentless Heart Valve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Biocor, Biocor Supra, Epic, Epic Supra Valves

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Cellex Photopheresis System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System