Data / Medical devices / United States / Volcano Corporation
Volcano Corporation: FDA-registered device maker in Rancho Cordova, CA, United States, 24 510(k) clearances
Volcano Corporation is registered with the FDA (registration 2939520) in Rancho Cordova, CA, United States. It lists 11 device types. The FDA files 24 510(k) clearances under its listings, the newest dated February 24, 2026. 18 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2939520
- Address
- 2451 Mercantile Drive, Rancho Cordova, CA, United States, 95742
- Owner or operator
- Philips Medical Systems International BV (2939520)
- Roles
- Manufacturer
- First device listed
- December 14, 2007
- Registered through
- 2026
- Brand names listed
- 300000629191, Upgrade Kit, SyncVision v4.1, 803521-001, 802745-001 ComboMap System, 803523-001 ComboMap Cart Kit, 806426-004 ComboMap Software v1.9 Upgrade Kit, 806426-008 ComboMap Software v1.9 Document Kit, 806426-012 ComboMap Software v2.1 Upgrade Kit, 807062-001 ComboMap Sterile Cover, CORE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Manufacturer | accessdata.fda.gov |
| Catheter For Crossing Total Occlusions | PDU | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Peripheral, Atherectomy | MCW | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2026 | K253714 | IntraSight Plus | IYO | Substantially Equivalent | Philips Image Guided Therapy Corporation | accessdata.fda.gov |
| January 19, 2021 | K203719 | IntraSight Mobile | IYO | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| September 28, 2020 | K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | DQX | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| May 22, 2020 | K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | OBJ | Substantially Equivalent | Philips Image Guided Therapy Corporation | accessdata.fda.gov |
| March 26, 2020 | K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | DQX | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| April 12, 2019 | K190626 | SyncVision System | OWB | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| February 11, 2019 | K190078 | IntraSight | DSA | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| October 5, 2017 | K172574 | SyncVision System | OWB | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| April 6, 2017 | K170385 | CORE M2 Vascular System | IYO | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| December 2, 2016 | K162418 | Pioneer Plus Catheter | PDU | Substantially Equivalent | Philips Volcano | accessdata.fda.gov |
| October 26, 2016 | K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| December 31, 2015 | K153094 | Visions PV .035 Digital IVUS Catheter | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| December 22, 2015 | K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | IYO | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| November 19, 2015 | K152829 | Visions PV.014P RX Digital IVUS Catheter | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| September 4, 2015 | K150442 | Volcano Visions PV .018 Digital IVUS Catheter | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| August 26, 2015 | K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| December 19, 2014 | K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip | MCW | Substantially Equivalent | Volcano Atheromed, Inc. | accessdata.fda.gov |
| December 20, 2013 | K133641 | CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE | IYO | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| December 12, 2013 | K132558 | SYNC-RX SYSTEM | OWB | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| January 14, 2013 | K123898 | VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM | IYO | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| January 27, 2012 | K113486 | VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM | IYO | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| October 8, 2008 | K082229 | S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM | IYO | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| December 1, 2005 | K052395 | STERILE EQUIPMENT COVERS | KKX | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| September 16, 1996 | K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE | ITX | Substantially Equivalent | Endosonics Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 19, 2022 | 89673 | Class II | Ongoing | SyncVision Systems, Model:.10, PN: 30000485688x, with software version 4.2.x | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be up | accessdata.fda.gov |
| November 7, 2018 | 83919 | Class II | Terminated | 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) s5ix Imaging System w | Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS). | accessdata.fda.gov |
| October 17, 2018 | 81882 | Class II | Terminated | Visions PV.035 Digital IVUS Catheter, Catalog Number/Part Number 88901/.173 Product Usage: The Volcano PV.035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal | Visions PV.035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter. | accessdata.fda.gov |
| March 22, 2018 | 79715 | Class II | Terminated | Philips Volcano CORE M2 Vascular System, Part #.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. | The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image. | accessdata.fda.gov |
| November 3, 2017 | 78569 | Class II | Terminated | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF.01; CORE Mobile Imaging System Refurbished REF.01-R; CORE Mobile Imaging System (240V) REF.07; CORE Mobile Imaging System Refurbished REF.07 | On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device. | accessdata.fda.gov |
| March 29, 2017 | 76885 | Class II | Terminated | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number:.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for th | High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging. | accessdata.fda.gov |
| April 25, 2016 | 73984 | Class II | Terminated | 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 qualitative and quantita | Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot | accessdata.fda.gov |
| February 5, 2016 | 73254 | Class II | Terminated | 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 sterilized. The sterile | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. | accessdata.fda.gov |
| July 22, 2015 | 71881 | Class II | Terminated | 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) is intended to faci | Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters. | accessdata.fda.gov |
| June 22, 2015 | 71654 | Class II | Terminated | 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 CORE Series Intravascul | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | accessdata.fda.gov |
| June 4, 2015 | 71537 | Class II | Terminated | 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 providing a cross-sectional i | During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture | accessdata.fda.gov |
| August 13, 2014 | 69049 | Class II | Terminated | 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. | Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product. | accessdata.fda.gov |
| August 24, 2012 | 63102 | Class II | Terminated | Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers:.01,.04,.01,.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medi | The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself. | accessdata.fda.gov |
| November 3, 2010 | 57282 | Not yet classified | Terminated | 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, 0.014" guidewire com | Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury. | accessdata.fda.gov |
| June 29, 2010 | 56794 | Not yet classified | Terminated | Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA. | Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment. | accessdata.fda.gov |
| June 11, 2010 | 60867 | Not yet classified | Terminated | 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 printout of physiologic | Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock. | accessdata.fda.gov |
| October 6, 2009 | 60842 | Not yet classified | Terminated | 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 and peripheral arterie | Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap. | accessdata.fda.gov |
| April 2, 2007 | 38324 | Not yet classified | Terminated | Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM) | During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Wire, Guide, Catheter
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Transducer, Ultrasonic, Diagnostic
Updated February 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.