EkoSonic Endovascular Device— 510(k) K191119
Substantially EquivalentBtg International, Inc.
FDA 510(k) clearance K191119 for EkoSonic Endovascular Device, Substantially Equivalent on 2019-08-23. Applicant: Btg International, Inc.. Device class: 2.
Clearance details
- Applicant
- Btg International, Inc.
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bothell, WA, US
Recent devices under product code QEY
view all- K260149 — Versus Catheter (VS110-9NB)
- K251318 — VariFuse Adjustable Infusion Catheter
- K241851 — Versus Catheter (VS110-8B)
- K231653 — BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
- K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
More clearances from Btg International, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.