Data / Medical devices / United States / Volcano Corporation
Volcano Corporation: FDA-registered device maker in San Diego, CA, United States, 42 510(k) clearances
Volcano Corporation is registered with the FDA (registration 3008363989) in San Diego, CA, United States. It lists 20 device types. The FDA files 42 510(k) clearances under its listings, the newest dated February 24, 2026. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008363989
- Address
- 3721 Valley Centre Dr Ste 500, San Diego, CA, United States, 92130
- Owner or operator
- Philips Medical Systems International BV (2939520)
- Roles
- Complaint file establishment, Specification developer
- 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, AA&TRAY ASSY, ADU, ZOLL MED 8000-0262 and more
Devices it lists
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 |
| October 24, 2025 | K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | DQK | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 14, 2024 | K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | DQK | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 15, 2021 | K210235 | Verrata PLUS Pressure Guide Wire | DQX | Substantially Equivalent | Volcano 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 |
| September 2, 2020 | K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | OBJ | Substantially Equivalent | Philips Image Guided Therapy 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 |
| May 4, 2020 | K193228 | Hamilton-G5 | CBK | Substantially Equivalent | Hamilton Medical AG | 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 |
| August 2, 2019 | K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| April 12, 2019 | K190626 | SyncVision System | OWB | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| March 19, 2019 | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | CBK | Substantially Equivalent | Maquet Critical Care AB | accessdata.fda.gov |
| February 11, 2019 | K190078 | IntraSight | DSA | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| October 25, 2017 | K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit | IYO | 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 |
| June 20, 2014 | K123149 | SERVO-I VENTILATOR SYSTEM | CBK | Substantially Equivalent | Maquet Critical Care AB | accessdata.fda.gov |
| March 7, 2014 | K140291 | VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS | IYO | Substantially Equivalent | Volcano Corporation | 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 |
| September 22, 2009 | K091572 | DISPOSABLE SPO2 SENSOR M1134A | DQA | Substantially Equivalent | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 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 |
| November 9, 2006 | K062605 | PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T | DQA | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| January 12, 2006 | K053174 | LOFLO C5 CO2 SENSOR | CCK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| December 1, 2005 | K052395 | STERILE EQUIPMENT COVERS | KKX | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| November 17, 2005 | K052377 | PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. | DQA | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| April 22, 2005 | K050762 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 | MHX | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| November 19, 2004 | K042601 | CAPNOSTAT 5 | CCK | Substantially Equivalent | Respironics Novametrix, Inc. | accessdata.fda.gov |
| October 15, 2004 | K042306 | PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A | DQA | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| May 8, 2002 | K021300 | MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B | DSI | Substantially Equivalent | Philips Medical Systems | 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 |
|---|---|---|---|---|---|---|
| August 6, 2026 | 99730 | Class II | Ongoing | Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA | Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. | accessdata.fda.gov |
| June 13, 2025 | 97192 | Class II | Ongoing | 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. | Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rap | accessdata.fda.gov |
| May 16, 2022 | 90292 | Class II | Terminated | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 | Due to a potential failed sterilization process. | accessdata.fda.gov |
| May 13, 2022 | 90252 | Class III | Ongoing | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | accessdata.fda.gov |
| February 3, 2022 | 89698 | Class III | Ongoing | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems | Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets. | accessdata.fda.gov |
| January 24, 2022 | 89677 | Class III | Ongoing | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information. | accessdata.fda.gov |
| September 23, 2013 | 71404 | Class II | Terminated | 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 -.01. Intravascular Imaging and Pressure System for eva | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output. | accessdata.fda.gov |
Compare with other makers
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- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
Updated September 25, 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.