| 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-0726-2019 | Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usag | October 17, 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-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-1775-2017 | Class II | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog | March 29, 2017 |
| Z-1776-2017 | Class II | Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.27 | 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-1042-2016 | Class II | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment cov | February 5, 2016 |
| Z-1041-2016 | Class II | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers a | 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-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-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-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-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-1845-2015 | Class II | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicat | June 4, 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 |