EkoSonic Endovascular Device, EKOS+ Endovascular Device— 510(k) K213422
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K213422 for EkoSonic Endovascular Device, EKOS+ Endovascular Device, Substantially Equivalent on 2021-12-14. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- 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
- Maple Grove, MN, US
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More clearances from Boston Scientific Corporation
view allRecalls naming K213422
K-number listed on FDA's recall record- Z-1491-2022 — EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
- Z-1492-2022 — EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213422.
Data sourced from openFDA. This site is unofficial and independent of the FDA.