Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009490946

FEI Number

3009490946

Entity Name

Volcano Corporation by Volcarica S.R.L.

City/State/Country

Coyol Alajuela, CR

Establishment Address

Coyol Free Zone and Business Park, Building B37, Coyol Alajuela none, CR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 2939520)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193228

PMA Number

N/A

All Registered Proprietary Names

OmniWire Pressure Guide Wire OmniWire Pressure Guide Wire Adhesive-free Neonatal/Infant/Adult Disposable SpO2 Sensor Eagle Eye Platinum ST RX Digital IVUS Catheter Eagle Eye Platinum RX Digital IVUS Catheter Reusable Adult SpO2 Clip Sensor(0.9m) Reusable Adult SpO2 Clip Sensor(3m) Reconnaissance PV 18 OTW Digital IVUS Catheter Visions PV 18 Digital IVUS Catheter Neonatal and Pediatric CO2 Airway Adapter, Reusable Pediatric and Adult CO2 Airway Adapter, Reusable Mainstream CO2 Sensor Reusable NEO Airway Adapter, Philips Reusable ADU-PED Airway Adapter, Philips Reusable Adult/Pediatric Ear Clip SpO2 Sensor(1.5m) Reusable Pediatric/Small/Adult Finger SpO2 Sensor Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m) Infant Disposable SpO2 Sensor Neonatal / Infant / Adult Disposable SpO2 Sensor Reusable Adult/Pediatric Airway Adapter ADULT AIRWAY ADAPTER, QTY 1, MAQUET Capnostat 5 Mainstream CO2 Sensor Capnography Sensor, Reusable LoFlo Module - RoHS - Private Label C5 LoFlo Sidestream Module Respironics Alice, LoFlo, C5 Sidestream Module Respironics LoFlo Sidestream CO2 Module Refinity ST Rotational IVUS Catheter CAPNOSTAT 5 Mainstream CO2 sensor Disposable Adult / Pediatric SpO2 Sensor Visions PV 14P RX Digital IVUS Catheter CAPNOSTAT 5 Mainstream CO2 sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
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
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-03-23
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2015-08-31
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
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2015-10-16
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-09-25
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-06-23
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2021-03-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-03-23
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-12-08
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-04-16
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-07-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-11-01
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2016-11-01
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
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-03-23
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2015-12-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-12-14
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-07-23

Official Correspondent

No official correspondent registered.

US Agent Details

Megan Olen Business: Philips Email: megan.olen@philips.com Phone: (719) 4472592

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
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009490946. Last updated year: 2026. Please use registration number 3009490946 when referencing this establishment in official correspondence.