Data / Medical devices / Costa Rica / Volcano Corporation by Volcarica S.R.L.
Volcano Corporation by Volcarica S.R.L.: FDA-registered device maker in Coyol Alajuela, Costa Rica, 21 510(k) clearances
Volcano Corporation by Volcarica S.R.L. is registered with the FDA (registration 3009490946) in Coyol Alajuela, Costa Rica. It lists 12 device types. The FDA files 21 510(k) clearances under its listings, the newest dated September 28, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009490946
- Address
- Coyol Free Zone and Business Park Building B37, Coyol Alajuela, Costa Rica, none
- Owner or operator
- Philips Medical Systems International BV (2939520)
- Roles
- Manufacturer
- First device listed
- August 31, 2015
- Registered through
- 2026
- Brand names listed
- AA&TRAY ASSY, ADU, ZOLL MED 8000-0262, ADULT AIRWAY ADAPTER, QTY 1, MAQUET, Adapter ADU Reuse Capnostat 704-0002-00, Adhesive-free Neonatal/Infant/Adult Disposable SpO2 Sensor, C5 LoFlo Sidestream Module, CAPNOSTAT 5 Mainstream CO2 sensor, CAPNOSTAT 5 Mainstream Sensor - RoHS - Private label, CAPNOSTAT 5 Mainstream Sensor, Maquet and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 28, 2020 | K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | DQX | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| September 2, 2020 | K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | OBJ | Substantially Equivalent | Philips Image Guided Therapy Corporation | accessdata.fda.gov |
| May 22, 2020 | K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | OBJ | Substantially Equivalent | Philips Image Guided Therapy Corporation | accessdata.fda.gov |
| May 4, 2020 | K193228 | Hamilton-G5 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| March 26, 2020 | K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | DQX | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| August 2, 2019 | K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| March 19, 2019 | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | CBK | Substantially Equivalent | Maquet Critical Care AB | accessdata.fda.gov |
| October 26, 2016 | K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| December 31, 2015 | K153094 | Visions PV .035 Digital IVUS Catheter | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| November 19, 2015 | K152829 | Visions PV.014P RX Digital IVUS Catheter | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| September 4, 2015 | K150442 | Volcano Visions PV .018 Digital IVUS Catheter | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| August 26, 2015 | K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM | OBJ | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| June 20, 2014 | K123149 | SERVO-I VENTILATOR SYSTEM | CBK | Substantially Equivalent | Maquet Critical Care AB | accessdata.fda.gov |
| September 22, 2009 | K091572 | DISPOSABLE SPO2 SENSOR M1134A | DQA | Substantially Equivalent | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | accessdata.fda.gov |
| November 9, 2006 | K062605 | PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T | DQA | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| January 12, 2006 | K053174 | LOFLO C5 CO2 SENSOR | CCK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| November 17, 2005 | K052377 | PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. | DQA | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| April 22, 2005 | K050762 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 | MHX | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| November 19, 2004 | K042601 | CAPNOSTAT 5 | CCK | Substantially Equivalent | Respironics Novametrix, Inc. | accessdata.fda.gov |
| October 15, 2004 | K042306 | PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A | DQA | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| May 8, 2002 | K021300 | MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B | DSI | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Wire, Guide, Catheter
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Oximeter
- All makers of Ventilator, Continuous, Facility Use
Updated September 28, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.