Volcano Corporation
FDA Regulatory Profile
Volcano Corporation appears in FDA public data with 22 recalls, 55 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0885-2022, Class II) was initiated on January 19, 2022. Its most recent 510(k) clearance was granted on April 15, 2021.
Summary
- Total Recalls
- 22
- 510(k) Clearances
- 55
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0885-2022 | Class II | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x | January 19, 2022 |
| Z-0674-2020 | Class II | Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and | November 7, 2018 |
| Z-0727-2019 | Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usag | October 17, 2018 |
| Z-0726-2019 | Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usag | October 17, 2018 |
| Z-1891-2018 | Class II | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative an | March 22, 2018 |
| Z-0189-2018 | Class II | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mo | November 3, 2017 |
| Z-1776-2017 | Class II | Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.27 | March 29, 2017 |
| Z-1775-2017 | Class II | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog | March 29, 2017 |
| Z-1813-2016 | Class II | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. C | April 25, 2016 |
| Z-1041-2016 | Class II | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers a | February 5, 2016 |
| Z-1042-2016 | Class II | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment cov | February 5, 2016 |
| Z-2718-2015 | Class II | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusion | July 22, 2015 |
| Z-2136-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without | June 22, 2015 |
| Z-2131-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and wi | June 22, 2015 |
| Z-2132-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without | June 22, 2015 |
| Z-2134-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without | June 22, 2015 |
| Z-2135-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without | June 22, 2015 |
| Z-2133-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without | June 22, 2015 |
| Z-1844-2015 | Class II | Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated f | June 4, 2015 |
| Z-1845-2015 | Class II | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicat | June 4, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210235 | Verrata PLUS Pressure Guide Wire | April 15, 2021 |
| K203719 | IntraSight Mobile | January 19, 2021 |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | September 28, 2020 |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | March 26, 2020 |
| K190626 | SyncVision System | April 12, 2019 |
| K190078 | IntraSight | February 11, 2019 |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and P | April 11, 2018 |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit | October 25, 2017 |
| K172574 | SyncVision System | October 5, 2017 |
| K170385 | CORE M2 Vascular System | April 6, 2017 |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | October 26, 2016 |
| K161887 | Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Ti | September 20, 2016 |
| K161756 | SyncVision System | September 5, 2016 |
| K153094 | Visions PV .035 Digital IVUS Catheter | December 31, 2015 |
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | December 22, 2015 |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | December 3, 2015 |
| K152829 | Visions PV.014P RX Digital IVUS Catheter | November 19, 2015 |
| K150442 | Volcano Visions PV .018 Digital IVUS Catheter | September 4, 2015 |
| K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM | August 26, 2015 |
| K151904 | SyncVision System | July 31, 2015 |