EkoSonic Endovascular System with Control Unit 4.0— 510(k) K162771
Substantially EquivalentBtg International, Inc.
FDA 510(k) clearance K162771 for EkoSonic Endovascular System with Control Unit 4.0, Substantially Equivalent on 2017-02-24. 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 K162771
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162771.
Data sourced from openFDA. This site is unofficial and independent of the FDA.