Medical Device Manufacturer · US , Rancho Cordova, , CA

Volcano Corporation

55 submissions · 55 cleared · Since 2005
55
Total
55
Cleared
0
Denied

Volcano Corporation — FDA 510(k) Submissions

Volcano Corporation has submitted 55 FDA 510(k) premarket notifications since 2005, of which 55 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Imaging, Pulsed Echo, Ultrasonic, Catheter, Ultrasound, Intravascular, Wire, Guide, Catheter, Interventional Fluoroscopic X-ray System, Catheter, Percutaneous . Use the specialty filter in the sidebar to narrow results.

55 devices
1–25 of 55
Verrata PLUS Pressure Guide Wire
K210235 · DQX Wire, Guide, Catheter · Cardiovascular
Apr 2021 77d
IntraSight Mobile
K203719 · IYO System, Imaging, Pulsed... · Cardiovascular
Jan 2021 29d
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
K202543 · DQX Wire, Guide, Catheter · Cardiovascular
Sep 2020 26d
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
K192886 · DQX Wire, Guide, Catheter · Cardiovascular
Mar 2020 168d
SyncVision System
K190626 · OWB Interventional... · Radiology
Apr 2019 32d
IntraSight
K190078 · DSA Cable, Transducer And... · Cardiovascular
Feb 2019 26d
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
K173860 · IYO System, Imaging, Pulsed... · Radiology
Apr 2018 112d
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
K172455 · IYO System, Imaging, Pulsed... · Radiology
Oct 2017 72d
SyncVision System
K172574 · OWB Interventional... · Radiology
Oct 2017 38d
CORE M2 Vascular System
K170385 · IYO System, Imaging, Pulsed... · Radiology
Apr 2017 57d
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
K160583 · OBJ Catheter, Ultrasound,... · Cardiovascular
Oct 2016 239d
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip
K161887 · DQX Wire, Guide, Catheter · Cardiovascular
Sep 2016 71d
SyncVision System
K161756 · OWB Interventional... · Radiology
Sep 2016 70d
Visions PV .035 Digital IVUS Catheter
K153094 · OBJ Catheter, Ultrasound,... · Cardiovascular
Dec 2015 66d
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
K153369 · IYO System, Imaging, Pulsed... · Radiology
Dec 2015 29d
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · DSK Computer, Blood-pressure · Cardiovascular
Dec 2015 84d
Visions PV.014P RX Digital IVUS Catheter
K152829 · OBJ Catheter, Ultrasound,... · Cardiovascular
Nov 2015 51d
Volcano Visions PV .018 Digital IVUS Catheter
K150442 · OBJ Catheter, Ultrasound,... · Cardiovascular
Sep 2015 196d
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM
K143701 · OBJ Catheter, Ultrasound,... · Cardiovascular
Aug 2015 245d
SyncVision System
K151904 · OWB Interventional... · Radiology
Jul 2015 18d
Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular
K150262 · DTK Filter, Intravascular,... · Cardiovascular
Apr 2015 58d
Volcano iFR Modality, iFR Scout feature
K150441 · IYO System, Imaging, Pulsed... · Radiology
Mar 2015 28d
Volcano iFR Harvest Software (Offline)
K143122 · IYO System, Imaging, Pulsed... · Radiology
Feb 2015 112d
VOLCANO IFR MODALITY
K133323 · IYO System, Imaging, Pulsed... · Radiology
Mar 2014 136d
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
K140291 · IYO System, Imaging, Pulsed... · Radiology
Mar 2014 30d
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