OBJ
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
- Advisory panel
- Cardiovascular
- Total cleared
- 77
Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OBJ
- K260816 — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)
- K253399 — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter
- K250955 — XC11 ICE System, USA
- K250913 — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
- K251211 — ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach
- K251231 — ViewFlex X ICE Catheter, Sensor Enabled
- K251103 — VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
- K242893 — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
- K241540 — NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter
- K240050 — SOUNDSTAR CRYSTAL Ultrasound Catheter
- K233948 — Provisio SLT IVUS System
- K233270 — AcuNav Crystal Ultrasound Catheter
- K230453 — OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
- K223766 — NUVISION NAV Ultrasound Catheter
- K223077 — ViewFlex Xtra ICE Catheter
- K222568 — OptiCross 18 Peripheral Imaging Catheter
- K213593 — OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
- K212959 — ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
- K201775 — NuVision ICE Catheter
- K203726 — ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
- K200812 — VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
- K200195 — NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
- K200410 — Reconnaissance PV .018 OTW Digital IVUS Catheter
- K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
- K191175 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
- K172258 — Novasight Hybrid System
- K173820 — OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
- K173618 — ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
- K173284 — OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)
- K173063 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
- K170263 — AcuNav Diagnostic Ultrasound Catheter 8F,10F
- K170992 — AcuNav V 10F Ultrasound Catheter
- K163478 — AcuNav Volume ICE Catheter
- K160583 — REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
- K160514 — OptiCross 18, 30 MHz Peripheral Imaging Catheter
- K161125 — OptiCross X, 40 MHz Coronary Imaging Catheter
- K153617 — OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
- K153094 — Visions PV .035 Digital IVUS Catheter
- K152829 — Visions PV.014P RX Digital IVUS Catheter
- K150442 — Volcano Visions PV .018 Digital IVUS Catheter
- K143701 — EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM
- K141618 — ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
- K133853 — VIEWFLEX XTRA ICE CATHETER
- K140318 — SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
- K132133 — CG+ ARROW JACC POWERED BY ARROW VPS STYLET
- K123621 — OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
- K123813 — VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
- K122878 — HD-IVUS ULTRASOUND IMAGING SYSTEM
- K121273 — VISIONS PV .035 DITITAL IVUS CATHETER
- K113008 — KODAMA INTRAVASCULAR ULRASOUND CATHETER
- K120697 — EAGLE EYE PLATINUM ST CATHETER
- K112050 — SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
- K111043 — ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
- K103255 — VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
- K103260 — VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
- K101138 — SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
- K092596 — EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
- K091352 — SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
- K092064 — SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
- K081626 — FLOWPICC CONSOLE
- K081625 — FLOWPICC STYLET
- K081808 — ACUNAV V ULTRASOUND CATHETER
- K080891 — REVOLUTION 45MHZ IVUS IMAGING CATHETER
- K073473 — EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700
- K071554 — VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
- K071660 — VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
- K071234 — ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
- K070242 — SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
- K051337 — EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001
- K051679 — ILAB ULTRASOUND IMAGING SYSTEM
- K050995 — REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER
- K042593 — ACUSON ACUNAV 8F ULTRASOUND CATHETER
- K041727 — MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
- K041134 — COMBOMAP PRESSURE AND FLOW SYSTEM
- K033650 — ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
- K031346 — JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
- K030524 — CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.