Volcano Corporation
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PhilipsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
- 510(k) clearances: 56
- Device recalls: 32
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Aug 6, 2026 | Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VAClass II · Software system may associate image data from one patient with another patient's record, potentially resulting in incor | Device recalls |
| Oct 28, 2025 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterK253399 · OBJ | 510(k) clearances |
| Jun 13, 2025 | Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with InstClass II · Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without | Device recalls |
| May 16, 2022 | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891Class II · Due to a potential failed sterilization process. | Device recalls |
| May 13, 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797Class III · Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Device recalls |
| May 13, 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797Class III · Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Device recalls |
| Feb 3, 2022 | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight IntegraClass III · Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may | Device recalls |
| Jan 24, 2022 | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102Class III · Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS sys | Device recalls |
| Apr 15, 2021 | Verrata PLUS Pressure Guide WireK210235 · DQX | 510(k) clearances |
| Jan 19, 2021 | IntraSight MobileK203719 · IYO | 510(k) clearances |
| Sep 28, 2020 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipK202543 · DQX | 510(k) clearances |
| Mar 26, 2020 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipK192886 · DQX | 510(k) clearances |
| Apr 12, 2019 | SyncVision SystemK190626 · OWB | 510(k) clearances |
| Feb 11, 2019 | IntraSightK190078 · DSA | 510(k) clearances |
| Apr 11, 2018 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy SystemK173860 · IYO | 510(k) clearances |
| Sep 23, 2013 | Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x Class II · A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, | Device recalls |
Canada and Imports
Matched by company name- Active Health Canada device licences
- 17, as of Nov 10, 2026
Names and Identifiers
- Appears as
- Website
- philips.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built