# Btg International, Inc.

- Location (FDA's records): Bothell, WA
- FDA decisions: 6 (2014–2019): 6 510(k) clearances
- Product codes: QEY (5), JXG (1)
- 510(k) review time since 2016: median 133 days, against 97 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 4 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Ekos Corp.: 1 (https://510kreport.com/company/ekos)

## Its most-cited devices
- K183361: EkoSonic Endovascular Device with Control Unit 4.0 (2019), cited by 2
- K191119: EkoSonic Endovascular Device (2019), cited by 2
- K182324: EkoSonic Endovascular System (2018), cited by 1
- K162771: EkoSonic Endovascular System with Control Unit 4.0 (2017), cited by 1
- K140151: Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit (2014), cited by 1

## Recent decisions
- K191119: EkoSonic Endovascular Device (Aug 23, 2019)
- K183361: EkoSonic Endovascular Device with Control Unit 4.0 (Apr 5, 2019)
- K182324: EkoSonic Endovascular System (Nov 26, 2018)
- K172035: EKOS ultrasound EVD Device, EVD Control Unit (Mar 24, 2018)
- K162771: EkoSonic Endovascular System with Control Unit 4.0 (Feb 24, 2017)
- K140151: Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit (May 21, 2014)

Source page: https://510kreport.com/company/btg-international
