GRAFT THROMBECTOMY INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Turbo-Power (2.0mm) Laser Atherectomy Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100

FDA 510(k)

FDA Class 2 ·Cardiovascular

XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

X-SIZER CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROTRACK

FDA 510(k)

FDA Class 2 ·Cardiovascular

REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HawkOne Directional Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pantheris Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRAC-WRIGHT TRAC 10 CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM NAVITUS L SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300

FDA 510(k)

FDA Class 2 ·Cardiovascular