FDA 510(k) Applications Submitted by VOLCANO CORPORATION
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K073473 |
12/11/2007 |
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 |
VOLCANO CORPORATION |
| K160583 |
03/01/2016 |
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip |
VOLCANO CORPORATION |
| K161887 |
07/11/2016 |
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 |
Volcano Corporation |
| K123482 |
11/13/2012 |
REFLOW ASPIRATION CATHETER |
VOLCANO CORPORATION |
| K153369 |
11/23/2015 |
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz |
VOLCANO CORPORATION |
| K170385 |
02/08/2017 |
CORE M2 Vascular System |
Volcano Corporation |
| K172455 |
08/14/2017 |
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit |
Volcano Corporation |
| K070487 |
02/20/2007 |
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX |
VOLCANO CORPORATION |
| K150262 |
02/04/2015 |
Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular |
Volcano Corporation |
| K161756 |
06/27/2016 |
SyncVision System |
Volcano Corporation |
| K151904 |
07/13/2015 |
SyncVision System |
VOLCANO CORPORATION |
| K132558 |
08/15/2013 |
SYNC-RX SYSTEM |
VOLCANO CORPORATION |
| K172574 |
08/28/2017 |
SyncVision System |
Volcano Corporation |
| K133142 |
10/17/2013 |
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION |
VOLCANO CORPORATION |
| K133681 |
12/02/2013 |
CRUX SNARE FILTER RETRIEVAL SET |
VOLCANO CORPORATION |
| K080891 |
03/31/2008 |
REVOLUTION 45MHZ IVUS IMAGING CATHETER |
VOLCANO CORPORATION |
| K071660 |
06/18/2007 |
VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 |
VOLCANO CORPORATION |
| K052348 |
08/29/2005 |
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV |
VOLCANO CORPORATION |
| K192886 |
10/10/2019 |
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip |
Volcano Corporation |
| K131288 |
05/06/2013 |
VERRATA PRESSURE GUIDE WIRE |
VOLCANO CORPORATION |
| K111706 |
06/17/2011 |
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
| K113486 |
11/23/2011 |
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
| K123898 |
12/18/2012 |
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
| K190078 |
01/16/2019 |
IntraSight |
Volcano Corporation |
| K210235 |
01/28/2021 |
Verrata PLUS Pressure Guide Wire |
Volcano Corporation |
| K122826 |
09/14/2012 |
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM |
VOLCANO CORPORATION |
| K203719 |
12/21/2020 |
IntraSight Mobile |
Volcano Corporation |
| K112035 |
07/15/2011 |
VALET MICRO CATHETER |
VOLCANO CORPORATION |
| K050995 |
04/20/2005 |
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER |
VOLCANO CORPORATION |
| K051337 |
05/23/2005 |
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 |
VOLCANO CORPORATION |
| K092596 |
08/24/2009 |
EAGLE EYE PLATINUM DIGITAL IVUS CATHETER |
VOLCANO CORPORATION |
| K071554 |
06/07/2007 |
VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
| K082229 |
08/07/2008 |
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM |
VOLCANO CORPORATION |
| K140291 |
02/05/2014 |
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS |
VOLCANO CORPORATION |
| K132659 |
08/26/2013 |
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM |
VOLCANO CORPORATION |
| K133641 |
11/27/2013 |
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE |
VOLCANO CORPORATION |
| K143701 |
12/24/2014 |
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM |
VOLCANO CORPORATION |
| K120697 |
03/07/2012 |
EAGLE EYE PLATINUM ST CATHETER |
VOLCANO CORPORATION |
| K100930 |
04/05/2010 |
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J |
VOLCANO CORPORATION |
| K121273 |
04/27/2012 |
VISIONS PV .035 DITITAL IVUS CATHETER |
VOLCANO CORPORATION |
| K111395 |
05/19/2011 |
PRIMEWIRE PRESTIGE PLUS |
VOLCANO CORPORATION |
| K150442 |
02/20/2015 |
Volcano Visions PV .018 Digital IVUS Catheter |
Volcano Corporation |
| K152829 |
09/29/2015 |
Visions PV.014P RX Digital IVUS Catheter |
Volcano Corporation |
| K060483 |
02/24/2006 |
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM |
VOLCANO CORPORATION |
| K061215 |
05/02/2006 |
VOLCANO S51 FAMILY OF IMAGING SYSTEMS |
VOLCANO CORPORATION |
| K051920 |
07/15/2005 |
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 |
VOLCANO CORPORATION |
| K052395 |
08/31/2005 |
STERILE EQUIPMENT COVERS |
VOLCANO CORPORATION |
| K152582 |
09/10/2015 |
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box |
VOLCANO CORPORATION |
| K150441 |
02/20/2015 |
Volcano iFR Modality, iFR Scout feature |
VOLCANO CORPORATION |
| K153094 |
10/26/2015 |
Visions PV .035 Digital IVUS Catheter |
Volcano Corporation |
| K133323 |
10/29/2013 |
VOLCANO IFR MODALITY |
VOLCANO CORPORATION |
| K143122 |
10/31/2014 |
Volcano iFR Harvest Software (Offline) |
Volcano Corporation |
| K173860 |
12/20/2017 |
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 |
Volcano Corporation |
| K202543 |
09/02/2020 |
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip |
Volcano Corporation |
| K190626 |
03/11/2019 |
SyncVision System |
Volcano Corporation |
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