AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Traxcess .007 Mini Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROPLEX COIL SYSTEM (MCS)

FDA 510(k)

FDA Class 2 ·Neurology

HEADWAY 17 MICROCATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYDROCOIL EMBOLIC SYSTEM (HES)

FDA 510(k)

FDA Class 2 ·Neurology

Wedge XL Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B

FDA 510(k)

FDA Class 2 ·Neurology

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)

FDA 510(k)

FDA Class 2 ·Neurology

SOFIA DISTAL ACCESS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISAAC Neurovascular Navigation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

HydroPearl Microspheres

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOFIA Plus Aspiration Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROPLEX COIL SYSTEM-COSMOS

FDA 510(k)

FDA Class 2 ·Neurology

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System

FDA 510(k)

FDA Class 2 ·Neurology

AZUR PUSHABLE 18 & 35 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYDROCOIL EMBOLIC SYSTEM (HES)

FDA 510(k)

FDA Class 2 ·Neurology

SOFIA 88 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35

FDA 510(k)

FDA Class 2 ·Cardiovascular

AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35

FDA 510(k)

FDA Class 2 ·Cardiovascular

AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610

FDA 510(k)

FDA Class 2 ·Cardiovascular