Volcano Therapeutics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Volcano Therapeutics, Inc. makes
Volcano Therapeutics, Inc. manufactures intravascular imaging and pressure/flow measurement devices, including guide wires (such as the ComboWire and ComboTip) for coronary and peripheral vascular procedures, as well as the Volcano IVUS System for intravascular ultrasound imaging. The company also produces the ComboMap Pressure and Flow System, which combines pressure and flow data to assess coronary artery lesions.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- CE MDD 510(k) 510(k)
Volcano Therapeutics, Inc. Volcano Ivus System Ref K042188
510(k) 510(k)Combomap Pressure And Flow System Ref K041134
510(k) 510(k)
Frequently asked questions
How many devices does Volcano Therapeutics, Inc. have in the registry?
The registry currently lists 3 devices for Volcano Therapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Volcano Therapeutics, Inc.'s devices?
Among its 3 most recently registered devices, Volcano Therapeutics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Volcano Therapeutics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Volcano Therapeutics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Volcano Therapeutics, Inc. in the registry?
The most recently registered devices listed for Volcano Therapeutics, Inc. include COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE, VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM and COMBOMAP PRESSURE AND FLOW SYSTEM.