Btg International, Inc.

FDA Regulatory Profile

Btg International, Inc. appears in FDA public data with 0 recalls, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Aug 23, 2019.

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K191119EkoSonic Endovascular DeviceAug 23, 2019
K183361EkoSonic Endovascular Device with Control Unit 4.0Apr 5, 2019
K182324EkoSonic Endovascular SystemNov 26, 2018
K172035EKOS ultrasound EVD Device, EVD Control UnitMar 24, 2018
K162771EkoSonic Endovascular System with Control Unit 4.0Feb 24, 2017
K140151EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNITMay 21, 2014