FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EkoSonic Endovascular Device
K Number: K191119
·
Decision Aug 23, 2019
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
70
Applicant Total
6
Review Days
119
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EkoSonic Endovascular Device
- K Number
- K191119
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Btg International, Inc.
- Date Received
- April 26, 2019
- Decision Date
- August 23, 2019
- Product Code
- QEY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QEY), ordered by most recent decision date.
Versus Catheter (VS110-9NB)
FDA 510(k)
FDA Class 2
·Cardiovascular
VariFuse Adjustable Infusion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Versus Catheter (VS110-8B)
FDA 510(k)
FDA Class 2
·Cardiovascular
BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
FDA 510(k)
FDA Class 2
·Cardiovascular
EKOS+ Endovascular Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Btg International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Apr 5, 2019 | Substantially Equivalent |
| K182324 | EkoSonic Endovascular System | Nov 26, 2018 | Substantially Equivalent |
| K172035 | EKOS ultrasound EVD Device, EVD Control Unit | Mar 24, 2018 | Substantially Equivalent |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Feb 24, 2017 | Substantially Equivalent |
| K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | May 21, 2014 | Substantially Equivalent |