Btg International, Inc.: FDA clearances and approvals
Btg International, Inc. has 6 FDA 510(k) clearances (first 2014, latest 2019), across 2 product codes in 2 review panels. Median 510(k) review time: 120 days. Since 2017 its median was 122 days, against 102 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 119 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 144 |
| 2018 | 2 | 176 |
| 2019 | 2 | 120 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Btg International, Inc.'s cleared 510(k)s took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | 5 | 5 |
| JXG | Shunt, Central Nervous System And Components | 1 | 1 |
Review panels
- Cardiovascular (5)
- Neurology (1)
Most recent Btg International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191119 | EkoSonic Endovascular Device | QEY | 2019-08-23 | 119 |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | QEY | 2019-04-05 | 122 |
| K182324 | EkoSonic Endovascular System | QEY | 2018-11-26 | 91 |
| K172035 | EKOS ultrasound EVD Device, EVD Control Unit | JXG | 2018-03-24 | 262 |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | QEY | 2017-02-24 | 144 |
| K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | QEY | 2014-05-21 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Btg International, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Btg International, Inc. have?
Btg International, Inc. has 6 FDA 510(k) clearances (first 2014, latest 2019), across 2 product codes in 2 review panels.
How long does FDA take to clear Btg International, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Btg International, Inc.'s cleared 510(k)s is 120 days. Since 2017: 122 days, versus 102 days for all cleared 510(k)s in the same product codes.
What devices does Btg International, Inc. make?
Its most frequent FDA product codes are QEY (Mechanical Thrombolysis Catheter, 5); JXG (Shunt, Central Nervous System And Components, 1).
Has Btg International, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Btg International, Inc. Related entities may recall under other names.
Next steps
- See all 6 Btg International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEY, Btg International, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.