Volcano Corporation

FDA Device Registration & Listing · San Diego, CA, US · Registration 3008363989

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008363989
FEI Number
3008363989
Entity Name
Volcano Corporation
City/State/Country
San Diego, CA, US
Establishment Address
3721 Valley Centre Dr Ste 500, San Diego, CA 92130, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Philips Medical Systems International BV (Owner Number: 2939520)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K042306
PMA Number
N/A

All Registered Proprietary Names

LoFlo Module - RoHS - Private Label C5 LoFlo Sidestream Module Respironics Alice, LoFlo, C5 Sidestream Module Respironics LoFlo Sidestream CO2 Module s5/s5i IVUS Imaging System CORE Control Pad PIM, Patient Interface module SyncRx SyncVision System Reusable Adult/Pediatric Ear Clip SpO2 Sensor(1.5m) Reusable Pediatric/Small/Adult Finger SpO2 Sensor Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m) Volcano CORE Control Pad, Accessory to the Volcano CORE/CORE Mobile Precision Guided Therapy Systems Sterile Equipment Covers Software v3.5 Verrata Plus Pressure Guide Wire IntraSight Plus LumiGuide 3D Hub LumiGuide Equipment R2.1 LumiGuide Wire OmniWire Pressure Guide Wire 806426-008 – ComboMap Software v1.9 Document Kit 806426-012 – ComboMap Software v2.1 Upgrade Kit 803523-001 – ComboMap Cart Kit 806426-004 – ComboMap Software v1.9 Upgrade Kit 807062-001 – ComboMap Sterile Cover 803521-001, 802745-001 – ComboMap System AltaTrack Equipment R1.2 AltaTrack Guidewire AltaTrack 3D Hub Infant Disposable SpO2 Sensor Neonatal / Infant / Adult Disposable SpO2 Sensor Reconnaissance PV 18 OTW Digital IVUS Catheter Mainstream CO2 Sensor Reusable NEO Airway Adapter, Philips Reusable ADU-PED Airway Adapter, Philips Reusable Adult SpO2 Clip Sensor(0.9m) Reusable Adult SpO2 Clip Sensor(3m) CAPNOSTAT 5 Mainstream Sensor, Maquet Reusable Adult/Pediatric Airway Adapter ADULT AIRWAY ADAPTER, QTY 1, MAQUET CAPNOSTAT 5 Mainstream CO2 sensor Visions PV 18 Digital IVUS Catheter Neonatal and Pediatric CO2 Airway Adapter, Reusable Pediatric and Adult CO2 Airway Adapter, Reusable CAPNOSTAT 5 Mainstream CO2 sensor Neonatal Airway Adapter AA&TRAY ASSY, ADU, ZOLL MED 8000-0262 CAPNOSTAT 5 Mainstream Sensor - RoHS - Private label Pediatric/Adult Airway Adapter Reusable Neonatal CO2 Airway Adapter Adapter ADU Reuse Capnostat 704-0002-00 Reusable Airway Adapter MaInstream CO2 Adult Zoll Neonatal Reusable Adapter, Qty 1 LumiGuide 3D Hub LumiGuide Equipment R2 LumiGuide Wire Adhesive-free Neonatal/Infant/Adult Disposable SpO2 Sensor s5i OmniWire Pressure Guide Wire R-100 Automatic Pullback Device IntraSight Visions PV 14P RX Digital IVUS Catheter Capnostat 5 Mainstream CO2 Sensor Capnography Sensor, Reusable Refinity ST Rotational IVUS Catheter Visions PV 35 Digital IVUS Catheter CORE M2 Vascular System Software v4.2 CORE M2 Vascular System Upgrade Kit, SyncVision v4.2 Disposable Adult / Pediatric SpO2 Sensor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-07-15
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2015-05-20
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2015-05-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-05-20
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2014-06-03
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2021-03-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-05-21
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2007-12-14
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2016-01-14
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-01-14
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2016-01-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2021-07-29
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2021-07-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-30
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2026-04-30
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2026-04-30
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-11-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-11-24
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2020-04-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-04-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-07-15
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2024-11-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-11-15
DQA Oximeter Cardiovascular Class 2 870.2700 2021-03-23
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-08-19
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-08-19
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2020-06-23
DQA Oximeter Cardiovascular Class 2 870.2700 2021-03-23
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-12-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-07-23
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2015-10-16
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2020-09-25
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-07-23
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2020-07-23
DQA Oximeter Cardiovascular Class 2 870.2700 2020-07-23
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2020-09-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-11-15
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2024-11-15
DQA Oximeter Cardiovascular Class 2 870.2700 2021-03-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-11-08
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2022-11-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2022-11-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2007-12-14
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2019-02-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-02-13
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2019-02-13
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2015-12-14
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-12-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-04-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-11-01
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2016-11-01
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2019-04-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-11-08
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2017-11-08
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-05-25
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2017-05-25
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2019-04-15
DQA Oximeter Cardiovascular Class 2 870.2700 2021-03-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038281851 Philips Polska Sp. z o.o. Lodz Lodzkie, PL
3003584029 Braemar Manufacturing, LLC San Diego, CA, US
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL
3008514395 Telcare, LLC Linwood, PA, US
3004961434 RESPIRATORY TECHNOLOGIES, INC. Plymouth, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042306 Philips Medizin Systeme Boeblingen GmbH PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A 2004-10-15
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26
K880323 Medtronic Vascular MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR 1988-03-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008363989. Last updated year: 2026. Please use registration number 3008363989 when referencing this establishment in official correspondence.
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