Company ยท US
Btg International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2019. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2019 | K191119 | EkoSonic Endovascular Device Btg International, Inc. | QEY |
| Apr 5, 2019 | K183361 | EkoSonic Endovascular Device with Control Unit 4.0 Btg International, Inc. | QEY |
| Nov 26, 2018 | K182324 | EkoSonic Endovascular System Btg International, Inc. | QEY |
| Mar 24, 2018 | K172035 | EKOS ultrasound EVD Device, EVD Control Unit Btg International, Inc. | JXG |
| Feb 24, 2017 | K162771 | EkoSonic Endovascular System with Control Unit 4.0 Btg International, Inc. | QEY |
| May 21, 2014 | K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT Btg International, Inc. | QEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||