AZUR Vascular Plug

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRAXCESS DOCKING WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415

FDA 510(k)

FDA Class 2 ·Neurology

MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)

FDA 510(k)

FDA Class 2 ·Neurology

AZUR DETACHABLE 35 PLATINUM COIL SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)

FDA 510(k)

FDA Class 2 ·Neurology

CHAPERON GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AZUR DETACHABLE 35

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V

FDA 510(k)

FDA Class 2 ·Neurology

MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10

FDA 510(k)

FDA Class 2 ·Neurology

SOFIA EX Intracranial Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)

FDA 510(k)

FDA Class 2 ·Neurology

MICROPLEX COIL SYSTEM (MCS), VFC

FDA 510(k)

FDA Class 2 ·Neurology

MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX

FDA 510(k)

FDA Class 2 ·Neurology

TRAXCESS 14 GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEADWAY 21 MICROCATHETER, MODEL: MC212150S

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)

FDA 510(k)

FDA Class 2 ·Neurology