Btg International, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What Btg International, Inc. makes
Btg International, Inc. manufactures ultrasound-guided endovascular devices, including the EKOS ultrasound Endovascular Device (EVD) and its associated control units. These systems are designed for clot removal and thrombus fragmentation in vascular procedures, utilizing ultrasound energy to break down blockages in blood vessels. The portfolio also includes the EkoSonic Endovascular System, which combines ultrasound technology with mechanical aspiration to treat peripheral artery disease and other vascular conditions.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States. The manufacturer is based in the US.
Catalogue
EKOS ultrasound EVD Device, EVD Control Unit Ref K172035
510(k) 510(k)- 510(k) 510(k)
EkoSonic Endovascular Device Ref K191119
510(k) 510(k)- 510(k) 510(k)
EkoSonic Endovascular System Ref K182324
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Btg International, Inc. have in the registry?
The registry currently lists 6 devices for Btg International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Btg International, Inc.'s devices?
Among its 6 most recently registered devices, Btg International, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Btg International, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Btg International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Btg International, Inc. in the registry?
The most recently registered devices listed for Btg International, Inc. include EKOS ultrasound EVD Device, EVD Control Unit, EkoSonic Endovascular System with Control Unit 4.0, EkoSonic Endovascular Device and EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT.