Company ยท US
Volcano Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2021. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
37recalls (1 in 12 months)
35recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 36 |
| OBJ | Catheter, Ultrasound, Intravascular | 24 |
| DQX | Wire, Guide, Catheter | 9 |
| OWB | Interventional Fluoroscopic X-Ray System | 6 |
| DQY | Catheter, Percutaneous | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DTK | Filter, Intravascular, Cardiovascular | 1 |
| DXO | Transducer, Pressure, Catheter Tip | 1 |
| DXQ | Blood Pressure Cuff | 1 |
| MMX | Device, Percutaneous Retrieval | 1 |
| OGX | 1 | |
| PDU | Catheter For Crossing Total Occlusions | 1 |
| QEZ | Aspiration Thrombectomy Catheter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 15, 2021 | K210235 | Verrata PLUS Pressure Guide Wire Volcano Corporation | DQX |
| Jan 19, 2021 | K203719 | IntraSight Mobile Volcano Corporation | IYO |
| Sep 28, 2020 | K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip Volcano Corporation | DQX |
| Mar 26, 2020 | K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip Volcano Corporation | DQX |
| Apr 12, 2019 | K190626 | SyncVision System Volcano Corporation | OWB |
| Feb 11, 2019 | K190078 | IntraSight Volcano Corporation | DSA |
| Apr 11, 2018 | K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, COR Volcano Corporation | IYO |
| Oct 25, 2017 | K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit Volcano Corporation | IYO |
| Oct 5, 2017 | K172574 | SyncVision System Volcano Corporation | OWB |
| Apr 6, 2017 | K170385 | CORE M2 Vascular System Volcano Corporation | IYO |
| Oct 26, 2016 | K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip Volcano Corporation | OBJ |
| Sep 20, 2016 | K161887 | Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pres Volcano Corporation | DQX |
| Sep 5, 2016 | K161756 | SyncVision System Volcano Corporation | OWB |
| Dec 31, 2015 | K153094 | Visions PV .035 Digital IVUS Catheter Volcano Corporation | OBJ |
| Dec 22, 2015 | K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz Volcano Corporation | IYO |
| Dec 3, 2015 | K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box Volcano Corporation | DSK |
| Nov 19, 2015 | K152829 | Visions PV.014P RX Digital IVUS Catheter Volcano Corporation | OBJ |
| Sep 4, 2015 | K150442 | Volcano Visions PV .018 Digital IVUS Catheter Volcano Corporation | OBJ |
| Aug 26, 2015 | K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM Volcano Corporation | OBJ |
| Jul 31, 2015 | K151904 | SyncVision System Volcano Corporation | OWB |
| Apr 3, 2015 | K150262 | Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular Volcano Corporation | DTK |
| Mar 20, 2015 | K150441 | Volcano iFR Modality, iFR Scout feature Volcano Corporation | IYO |
| Feb 20, 2015 | K143122 | Volcano iFR Harvest Software (Offline) Volcano Corporation | IYO |
| Mar 14, 2014 | K133323 | VOLCANO IFR MODALITY Volcano Corporation | IYO |
| Mar 7, 2014 | K140291 | VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS Volcano Corporation | IYO |
| Jan 30, 2014 | K133681 | CRUX SNARE FILTER RETRIEVAL SET Volcano Corporation | MMX |
| Dec 20, 2013 | K133641 | CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE Volcano Corporation | IYO |
| Dec 12, 2013 | K132558 | SYNC-RX SYSTEM Volcano Corporation | OWB |
| Nov 15, 2013 | K133142 | VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION Volcano Corporation | IYO |
| Sep 27, 2013 | K132659 | VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM Volcano Corporation | DQY |
| Jun 21, 2013 | K131288 | VERRATA PRESSURE GUIDE WIRE Volcano Corporation | DQX |
| Apr 29, 2013 | K123482 | REFLOW ASPIRATION CATHETER Volcano Corporation | QEZ |
| Apr 24, 2013 | K122826 | PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM Volcano Corporation | DQY |
| Jan 14, 2013 | K123898 | VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM Volcano Corporation | IYO |
| Sep 10, 2012 | K121273 | VISIONS PV .035 DITITAL IVUS CATHETER Volcano Corporation | OBJ |
| Apr 5, 2012 | K120697 | EAGLE EYE PLATINUM ST CATHETER Volcano Corporation | OBJ |
| Jan 27, 2012 | K113486 | VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM Volcano Corporation | IYO |
| Jan 5, 2012 | K112035 | VALET MICRO CATHETER Volcano Corporation | DQY |
| Aug 1, 2011 | K111395 | PRIMEWIRE PRESTIGE PLUS Volcano Corporation | DQX |
| Jul 15, 2011 | K111706 | VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM Volcano Corporation | IYO |
| Apr 30, 2010 | K100930 | PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J Volcano Corporation | DQX |
| Dec 10, 2009 | K092596 | EAGLE EYE PLATINUM DIGITAL IVUS CATHETER Volcano Corporation | OBJ |
| Oct 8, 2008 | K082229 | S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM Volcano Corporation | IYO |
| May 12, 2008 | K080891 | REVOLUTION 45MHZ IVUS IMAGING CATHETER Volcano Corporation | OBJ |
| Jan 14, 2008 | K073473 | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 Volcano Corporation | OBJ |
| Jan 4, 2008 | K071554 | VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM Volcano Corporation | OBJ |
| Aug 31, 2007 | K071660 | VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 Volcano Corporation | OBJ |
| Mar 16, 2007 | K070487 | SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX Volcano Corporation | DXO |
| Aug 10, 2006 | K061215 | VOLCANO S51 FAMILY OF IMAGING SYSTEMS Volcano Corporation | IYO |
| Jun 23, 2006 | K060483 | VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM Volcano Corporation | IYO |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Volcano Corp Philips IntraSight Plus
REF: 797423 and 797417
100-120v-220-240v,50/60hZ, 1000 VA Open, Classified |
IYO | K253714 |
| Jul 30, 2025 | Volcano Corp Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use. Open, Classified |
OBJ | K150442 K152829 |
| May 16, 2022 | Volcano Corp Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 Terminated |
DXQ | K202543 |
| May 13, 2022 | Volcano Corp Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797 Open, Classified |
OBJ | K153094 |
| May 13, 2022 | Volcano Corp Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 Open, Classified |
OBJ | K121273 |
| Feb 3, 2022 | Volcano Corp MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems Open, Classified |
DSA | None listed |
| Jan 24, 2022 | Volcano Corp IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 Open, Classified |
IYO | K203719 |
| Jan 19, 2022 | Volcano Corporation SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x Open, Classified |
OWB | K132558 K151904 +3 |
| Dec 12, 2019 | Volcano Corporation Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s Terminated |
IYO | K170133 |
| Oct 17, 2018 | Volcano Corporation Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272
Product Usage:
The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultra Terminated |
OBJ | K153094 |
| Oct 17, 2018 | Volcano Corporation Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173
Product Usage:
The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultra Terminated |
OBJ | K121273 |
| May 17, 2018 | Volcano Corporation Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only.
Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the periphera Terminated |
IYO | K172455 |
| Nov 3, 2017 | Volcano Corporation Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07 Terminated |
OBJ | K071554 K123898 |
| Apr 10, 2017 | Volcano Corporation Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter;
Product number: 400-0200.273; Catalog number 89900.
Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (R Terminated |
OBJ | K160583 |
| Apr 10, 2017 | Volcano Corporation Refinity Rotational Intravascular Ultrasound (IVUS) Catheter;
Product number: 400-0200.289; Catalog number 89800.
Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or Terminated |
OBJ | K160583 |
| Apr 25, 2016 | Volcano Corporation Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits.
Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qua Terminated |
OBJ | K071554 K123898 |
| Mar 3, 2016 | Volcano Corporation Volcano SpinVision Sterile Equip cover II; Sterile;
General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot b Terminated |
KKX | K052395 |
| Mar 3, 2016 | Volcano Corporation Volcano R100 Sterile Equipment Cover; Sterile;
General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be ste Terminated |
KKX | K052395 |
| Sep 2, 2015 | Volcano Corporation Volcano Pioneer Plus Re-Entry Catheter;
Product Code PPLUS20, Catheter for Crossing Total Occlusions.
Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus Terminated |
PDU | K081804 K101777 |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model CORE
Radiology: The Volcano s5/s5i and COR Terminated |
IYO | K123898 |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model s5ix/s5iz
Radiology: The Volcano s5/s5i an Terminated |
IYO | K123898 |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model s5i
Radiology: The Volcano s5/s5i and CORE Terminated |
IYO | K123898 |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model CORE Mobile.
Radiology: The Volcano s5/s5i Terminated |
IYO | K123898 |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model s5x.
Radiology: The Volcano s5/s5i and CORE Terminated |
IYO | K123898 |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model s5.
Radiology: The Volcano s5/s5i and C Terminated |
IYO | K123898 |
| Jul 8, 2015 | Volcano Corp ComboMap Intravascular Flow and Pressure System;
Product/Part number: Combo Map - 802745-001.
Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular struct Terminated |
IYO | K082229 |
| Jul 8, 2015 | Volcano Corp Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging
and Pressure System;
Product/Part numbers: s5i -806300-020 ;
s5ix/s5iz - 807400-001;
CORE - 400-0 I 00.02.
Intravascular Imaging and Pr Terminated |
IYO | K123898 |
| Jul 8, 2015 | Volcano Corp Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014;
s5x - 807300-001; CORE MOBILE - 400-0100.01.
Intravascular Ima Terminated |
IYO | K123898 |
| Jun 25, 2015 | Volcano Corporation Prestige Plus 185cm J-Tip:
Part number: 9185J;
Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during Terminated |
DQX | K111395 |
| Jun 25, 2015 | Volcano Corporation Volcano PV .035 Catheter:
Part number: 88901;
Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by provi Terminated |
OBJ | K121273 |
| Sep 12, 2014 | Volcano Corporation Volcano TrakBack II Disposable Pullback Device;
Sterile and nonpyrogenic; Single Use.
TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data. Terminated |
DQO | K003938 |
| Sep 10, 2012 | Volcano Corporation Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and dist Terminated |
IYO | K082229 K111706 |
| Feb 7, 2012 | Volcano Corporation Volcano pcFM Software Kit ;
Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624.
The volcano pcFM Software Kit is a research only off line tool intended for review and p Terminated |
IYO | None listed |
| Feb 1, 2012 | Volcano Corporation FloWire Doppler Guide wires.
Volcano Corporation,
Rancho Cardova, Ca.
The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary Terminated |
DQX | K972762 |
| Nov 23, 2010 | Volcano Corporation Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user Terminated |
OGX | K071529 |
| Nov 1, 2010 | Volcano Corporation Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA. Terminated |
IYO | K082229 |
| Aug 23, 2007 | Volcano Corporation Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM) Terminated |
IYO | K051920 |