Volcano Corporation
Volcano Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2021, with 22 FDA device recalls on record.
Top product codes for Volcano Corporation
FDA recalls by Volcano Corporation
10 most recent of 22- Z-0885-2022 — SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
- Z-0674-2020 — 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 with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.
- Z-0727-2019 — Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.
- Z-0726-2019 — Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.
- Z-1891-2018 — Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
- Z-0189-2018 — Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished REF 400-0100.08-R; CORE Imaging System REF 400-0100.02 For intravascular ultrasound imaging.
- Z-1776-2017 — Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
- Z-1775-2017 — Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
- Z-1813-2016 — 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 quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
- Z-1041-2016 — 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 drapes are put over this equipment in case any sterile items may come into contact with them.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Volcano Corporation
- K210235 — Verrata PLUS Pressure Guide Wire
- K203719 — IntraSight Mobile
- K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K190626 — SyncVision System
- K190078 — IntraSight
- K173860 — s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
- K172455 — CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
- K172574 — SyncVision System
- K170385 — CORE M2 Vascular System
- K160583 — REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
- K161887 — Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip
- K161756 — SyncVision System
- K153094 — Visions PV .035 Digital IVUS Catheter
- K153369 — SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
- K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
- K152829 — Visions PV.014P RX Digital IVUS Catheter
- K150442 — Volcano Visions PV .018 Digital IVUS Catheter
- K143701 — EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM
- K151904 — SyncVision System
- K150262 — Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular
- K150441 — Volcano iFR Modality, iFR Scout feature
- K143122 — Volcano iFR Harvest Software (Offline)
- K133323 — VOLCANO IFR MODALITY
- K140291 — VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
- K133681 — CRUX SNARE FILTER RETRIEVAL SET
- K133641 — CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
- K132558 — SYNC-RX SYSTEM
- K133142 — VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
- K132659 — VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
- K131288 — VERRATA PRESSURE GUIDE WIRE
- K123482 — REFLOW ASPIRATION CATHETER
- K122826 — PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM
- K123898 — VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
- K121273 — VISIONS PV .035 DITITAL IVUS CATHETER
- K120697 — EAGLE EYE PLATINUM ST CATHETER
- K113486 — VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
- K112035 — VALET MICRO CATHETER
- K111395 — PRIMEWIRE PRESTIGE PLUS
- K111706 — VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
- K100930 — PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
- K092596 — EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
- K082229 — S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
- K080891 — REVOLUTION 45MHZ IVUS IMAGING CATHETER
- K073473 — EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700
- K071554 — VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
- K071660 — VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
- K070487 — SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
- K061215 — VOLCANO S51 FAMILY OF IMAGING SYSTEMS
- K060483 — VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM
- K052348 — IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
- K052395 — STERILE EQUIPMENT COVERS
- K051920 — VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
- K051337 — EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001
- K050995 — REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.