AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100

FDA 510(k)

FDA Class 2 ·Cardiovascular

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURBO-TANDEM SYSTEM MODEL 472-110

FDA 510(k)

FDA Class 2 ·Cardiovascular

Revolution Peripheral Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rotarex Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEANER ROTATIONAL THROMBECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rotarex Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEANER ROTATIONAL THROMBECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pantheris LV Atherectomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular