FDA.reportPublic FDA data

VOLCANO CORPORATION

Matched from indexed company URL: Volcano Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29395202939520VOLCANO CORPORATION1N2026-01-012451 Mercantile Drive Rancho Cordova CA US 95742
30083639893008363989Volcano Corporation1Y2026-01-013721 Valley Centre Dr Ste 500 San Diego CA US 92130
30088471913008847191Volcano AtheroMed Inc.1N2020-04-251530 O'Brien Drive, Suite A Menlo Park CA US 94025

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00845225003005QuickClear Aspiration Pump - P3223ASP(800) 228-4728IGTD.CustomerInquiry@philips.com
00845225003012QuickClear Aspiration Pump - P3223(800) 228-4728IGTD.CustomerInquiry@philips.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
85121837418894K972762CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRESDQX1997-10-14
85121670643873K962293ENDOSONICS AUTOMATIC PULL BACK DEVICEITX1996-09-16
1152841670643873K962293ENDOSONICS AUTOMATIC PULL BACK DEVICEITX1996-09-16
85121733045256K253714IntraSight PlusIYO2026-02-24
1152841733045256K253714IntraSight PlusIYO2026-02-24
1152841346682307K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubDQK2025-10-24
1152841649109373K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubDQK2024-03-14
1152841219102545K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubDQK2023-06-08
1152841366813719K210235Verrata PLUS Pressure Guide WireDQX2021-04-15
85121647270320K203719IntraSight MobileIYO2021-01-19
1152841647270320K203719IntraSight MobileIYO2021-01-19
85121505123618K202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipDQX2020-09-28
1152841505123618K202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipDQX2020-09-28
1152841531755662K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterDQK2020-12-17
1152841819362590K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterOBJ2020-09-02
85121773120415K200410Reconnaissance PV .018 OTW Digital IVUS CatheterOBJ2020-05-22
1152841773120415K200410Reconnaissance PV .018 OTW Digital IVUS CatheterOBJ2020-05-22
1152841638468414K193228Hamilton-G5CBK2020-05-04
85121742659893K192886OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipDQX2020-03-26
1152841742659893K192886OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipDQX2020-03-26
85121933727568K190626SyncVision SystemOWB2019-04-12
1152841933727568K190626SyncVision SystemOWB2019-04-12
85121326622506K190078IntraSightDSA2019-02-11
1152841326622506K190078IntraSightDSA2019-02-11
2000771285971218K182972Phoenix Atherectomy SystemMCW2018-12-20
1152841037415497K181216HAMILTON-T1, HAMILTON-C1CBK2019-08-02
1152841339585341K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK2019-03-19
85121724544207K172574SyncVision SystemOWB2017-10-05
1152841724544207K172574SyncVision SystemOWB2017-10-05
85121841340265K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation KitIYO2017-10-25
1152841841340265K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation KitIYO2017-10-25
2000771837534181K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy SystemMCW2017-08-24
85121180606149K170385CORE M2 Vascular SystemIYO2017-04-06
1152841180606149K170385CORE M2 Vascular SystemIYO2017-04-06
85121310885080K170133FFR V2.5IYO2017-05-26
85121856790263K162418Pioneer Plus CatheterPDU2016-12-02
1152841856790263K162418Pioneer Plus CatheterPDU2016-12-02
1152841706182123K161887Verrata 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-TipDQX2016-09-20
85121668505213K161756SyncVision SystemOWB2016-09-05
1152841668505213K161756SyncVision SystemOWB2016-09-05
85121269229229K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipOBJ2016-10-26
1152841269229229K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipOBJ2016-10-26
85121411905401K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izIYO2015-12-22
1152841411905401K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izIYO2015-12-22
85121880454459K153094Visions PV .035 Digital IVUS CatheterOBJ2015-12-31
1152841880454459K153094Visions PV .035 Digital IVUS CatheterOBJ2015-12-31
85121108053517K152829Visions PV.014P RX Digital IVUS CatheterOBJ2015-11-19
1152841108053517K152829Visions PV.014P RX Digital IVUS CatheterOBJ2015-11-19
85121150485991K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK2015-12-03
1152841150485991K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK2015-12-03
85121111383858K151904SyncVision SystemOWB2015-07-31
1152841111383858K151904SyncVision SystemOWB2015-07-31
2000771084096469K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemMCW2015-05-26
85121519726169K150442Volcano Visions PV .018 Digital IVUS CatheterOBJ2015-09-04
1152841519726169K150442Volcano Visions PV .018 Digital IVUS CatheterOBJ2015-09-04
85121983190274K150441Volcano iFR Modality, iFR Scout featureIYO2015-03-20
1152842066359795K150262Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugularDTK2015-04-03
85121597140520K143701EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUMOBJ2015-08-26
1152841597140520K143701EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUMOBJ2015-08-26
85121923581339K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support ClipMCW2014-12-19
1152841923581339K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support ClipMCW2014-12-19
2000771923581339K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support ClipMCW2014-12-19
85121772716116K143122Volcano iFR Harvest Software (Offline)IYO2015-02-20
2000771867817755K1409441.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIPMCW2014-08-22
85121246251849K140291VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMSIYO2014-03-07
1152841246251849K140291VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMSIYO2014-03-07
85121093547842K133641CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILEIYO2013-12-20
1152841093547842K133641CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILEIYO2013-12-20
85121088700606K133323VOLCANO IFR MODALITYIYO2014-03-14
85121077511271K133142VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISIONIYO2013-11-15
85121468462947K132558SYNC-RX SYSTEMOWB2013-12-12
1152841468462947K132558SYNC-RX SYSTEMOWB2013-12-12
85121657505990K131288VERRATA PRESSURE GUIDE WIREDQX2013-06-21
1152841657505990K131288VERRATA PRESSURE GUIDE WIREDQX2013-06-21
85121234126445K123898VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEMIYO2013-01-14
1152841234126445K123898VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEMIYO2013-01-14
1152841274347077K123149SERVO-I VENTILATOR SYSTEMCBK2014-06-20
85121320632040K122585CRUX VENA CAVA FILTER SYSTEMDTK2013-01-17
85121192730211K121273VISIONS PV .035 DITITAL IVUS CATHETEROBJ2012-09-10
85121048265895K120697EAGLE EYE PLATINUM ST CATHETEROBJ2012-04-05
1152841048265895K120697EAGLE EYE PLATINUM ST CATHETEROBJ2012-04-05
85121854432645K120402CRUX VENA CAVA FILTER SYSTEMDTK2012-07-13
85121665169175K113486VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEMIYO2012-01-27
1152841665169175K113486VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEMIYO2012-01-27
85121443437517K112035VALET MICRO CATHETERDQY2012-01-05
1152841443437517K112035VALET MICRO CATHETERDQY2012-01-05
85121617306220K111706VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEMIYO2011-07-15
85121726153292K111395PRIMEWIRE PRESTIGE PLUSDQX2011-08-01
1152841726153292K111395PRIMEWIRE PRESTIGE PLUSDQX2011-08-01
85121192475415K101777PIONEER PLUS CATHETER, MODEL PLUS 120PDU2010-07-23
1152841192475415K101777PIONEER PLUS CATHETER, MODEL PLUS 120PDU2010-07-23
85121220750261K100930PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300JDQX2010-04-30
85121473823945K100849SYNC-RX SYSTEM, MODEL AS00010IZI2010-05-21
85121075047446K092596EAGLE EYE PLATINUM DIGITAL IVUS CATHETEROBJ2009-12-10
1152841075047446K092596EAGLE EYE PLATINUM DIGITAL IVUS CATHETEROBJ2009-12-10
1152841406831359K091572DISPOSABLE SPO2 SENSOR M1134ADQA2009-09-22
85121929795393K082229S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEMIYO2008-10-08
1152841929795393K082229S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEMIYO2008-10-08
85121384930204K080891REVOLUTION 45MHZ IVUS IMAGING CATHETEROBJ2008-05-12
2000771097788854K080144MANDREL GUIDEWIRES OR M-WIRESDQX2008-02-26
85121815888548K071660VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900OBJ2007-08-31
85121173721181K071554VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEMOBJ2008-01-04
1152841187635530K062605PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196TDQA2006-11-09
85121325670122K061215VOLCANO S51 FAMILY OF IMAGING SYSTEMSIYO2006-08-10
1152841542234415K053174LOFLO C5 CO2 SENSORCCK2006-01-12
85121476196658K052395STERILE EQUIPMENT COVERSKKX2005-12-01
1152841476196658K052395STERILE EQUIPMENT COVERSKKX2005-12-01
1152841954288797K052377PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.DQA2005-11-17
85122071852789K052348IN VISION GOLD WITH SPIN VISION, MODEL 891 SVIYO2005-12-02
85121026467649K051920VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001IYO2005-08-19
85121491036481K051337EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001OBJ2005-08-18
85121657833131K050995REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETEROBJ2005-06-20
1152841949982063K050762PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90MHX2005-04-22
85121677090482K042996COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIREDQX2004-11-24
1152841556834223K042601CAPNOSTAT 5CCK2004-11-19
1152841329734640K042306PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131ADQA2004-10-15
85121830006438K041134COMBOMAP PRESSURE AND FLOW SYSTEMOBJ2004-06-02
1152841586871128K021300MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275BDSI2002-05-08
85121183889520K021219SMARTWIRE/SMARTMAP PRESSURE SYSTEMDQX2002-05-17
85121932667206K003938TRAK BACK IIDQO2001-01-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYO292026-02-24
OBJ242020-09-02
DQX152021-04-15
OWB102019-04-12
MCW72018-12-20
DQK42025-10-24
CBK42020-05-04
PDU42016-12-02
DQA42009-09-22
DTK32015-04-03
DSA22019-02-11
DSK22015-12-03
DQY22012-01-05
CCK22006-01-12
KKX22005-12-01
ITX21996-09-16
IZI12010-05-21
MHX12005-04-22
DSI12002-05-08
DQO12001-01-18

PMN#

65 records. Showing 1-40. Next

GUDID#

78 records. Showing 1-40. Next