FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EkoSonic Endovascular Device
K Number: K211080
·
Decision Nov 19, 2021
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
70
Applicant Total
58
Review Days
221
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
- K211080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- April 12, 2021
- Decision Date
- November 19, 2021
- 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 Boston Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Apr 8, 2026 | Substantially Equivalent |
| K252910 | Orca Air/Water and Suction Valves | Oct 9, 2025 | Unknown |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Jul 3, 2025 | Substantially Equivalent |
| K250468 | iSLEEVE Introducer Set | Mar 20, 2025 | Substantially Equivalent |
| K242950 | WallFlex Biliary PLUS RX Stent System | Dec 6, 2024 | Unknown |
| K242507 | OBSIDIO Conformable Embolic | Oct 3, 2024 | Substantially Equivalent |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Aug 30, 2024 | Unknown |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Apr 29, 2024 | Substantially Equivalent |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Mar 13, 2024 | Substantially Equivalent |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Nov 28, 2023 | Substantially Equivalent |