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Volcano Corporation

55 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Verrata PLUS Pressure Guide Wire (K210235)Volcano Corporation2021-04-15
IntraSight Mobile (K203719)Volcano Corporation2021-01-19
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K202543)Volcano Corporation2020-09-28
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K192886)Volcano Corporation2020-03-26
SyncVision System (K190626)Volcano Corporation2019-04-12
IntraSight (K190078)Volcano Corporation2019-02-11
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 (K173860)Volcano Corporation2018-04-11
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (K172455)Volcano Corporation2017-10-25
SyncVision System (K172574)Volcano Corporation2017-10-05
CORE M2 Vascular System (K170385)Volcano Corporation2017-04-06
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip (K160583)Volcano Corporation2016-10-26
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 (K161887)Volcano Corporation2016-09-20
SyncVision System (K161756)Volcano Corporation2016-09-05
Visions PV .035 Digital IVUS Catheter (K153094)Volcano Corporation2015-12-31
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz (K153369)Volcano Corporation2015-12-22
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (K152582)Volcano Corporation2015-12-03
Visions PV.014P RX Digital IVUS Catheter (K152829)Volcano Corporation2015-11-19
Volcano Visions PV .018 Digital IVUS Catheter (K150442)Volcano Corporation2015-09-04
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM (K143701)Volcano Corporation2015-08-26
SyncVision System (K151904)Volcano Corporation2015-07-31
Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular (K150262)Volcano Corporation2015-04-03
Volcano iFR Modality, iFR Scout feature (K150441)Volcano Corporation2015-03-20
Volcano iFR Harvest Software (Offline) (K143122)Volcano Corporation2015-02-20
VOLCANO IFR MODALITY (K133323)Volcano Corporation2014-03-14
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS (K140291)Volcano Corporation2014-03-07
CRUX SNARE FILTER RETRIEVAL SET (K133681)Volcano Corporation2014-01-30
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE (K133641)Volcano Corporation2013-12-20
SYNC-RX SYSTEM (K132558)Volcano Corporation2013-12-12
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION (K133142)Volcano Corporation2013-11-15
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM (K132659)Volcano Corporation2013-09-27
VERRATA PRESSURE GUIDE WIRE (K131288)Volcano Corporation2013-06-21
REFLOW ASPIRATION CATHETER (K123482)Volcano Corporation2013-04-29
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM (K122826)Volcano Corporation2013-04-24
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM (K123898)Volcano Corporation2013-01-14
VISIONS PV .035 DITITAL IVUS CATHETER (K121273)Volcano Corporation2012-09-10
EAGLE EYE PLATINUM ST CATHETER (K120697)Volcano Corporation2012-04-05
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM (K113486)Volcano Corporation2012-01-27
VALET MICRO CATHETER (K112035)Volcano Corporation2012-01-05
PRIMEWIRE PRESTIGE PLUS (K111395)Volcano Corporation2011-08-01
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM (K111706)Volcano Corporation2011-07-15
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J (K100930)Volcano Corporation2010-04-30
EAGLE EYE PLATINUM DIGITAL IVUS CATHETER (K092596)Volcano Corporation2009-12-10
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM (K082229)Volcano Corporation2008-10-08
REVOLUTION 45MHZ IVUS IMAGING CATHETER (K080891)Volcano Corporation2008-05-12
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 (K073473)Volcano Corporation2008-01-14
VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM (K071554)Volcano Corporation2008-01-04
VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 (K071660)Volcano Corporation2007-08-31
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX (K070487)Volcano Corporation2007-03-16
VOLCANO S51 FAMILY OF IMAGING SYSTEMS (K061215)Volcano Corporation2006-08-10
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM (K060483)Volcano Corporation2006-06-23
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV (K052348)Volcano Corporation2005-12-02
STERILE EQUIPMENT COVERS (K052395)Volcano Corporation2005-12-01
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 (K051920)Volcano Corporation2005-08-19
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 (K051337)Volcano Corporation2005-08-18
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER (K050995)Volcano Corporation2005-06-20

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Every clearance here is in the API, with alerts when new ones post.