ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled

FDA 510(k)

FDA Class 2 ·Cardiovascular

Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Auryon Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

FDA 510(k)

FDA Class 2 ·Cardiovascular

GELBFISH ENDO-VAC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pantheris System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES