EkoSonic Endovascular Device with Control Unit 4.0— 510(k) K183361
Substantially EquivalentBtg International, Inc.
FDA 510(k) clearance K183361 for EkoSonic Endovascular Device with Control Unit 4.0, Substantially Equivalent on 2019-04-05. 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
- Traditional
- Location
- Bothell, WA, US
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More clearances from Btg International, Inc.
view allRecalls naming K183361
K-number listed on FDA's recall record- Z-0149-2023 — EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
- Z-0637-2021 — EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183361.
Data sourced from openFDA. This site is unofficial and independent of the FDA.