EkoSonic Endovascular Device— 510(k) K211080

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K211080 for EkoSonic Endovascular Device, Substantially Equivalent on 2021-11-19. Applicant: Boston Scientific. Device class: 2.

Clearance details

Applicant
Boston Scientific
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
Download summary PDFView on FDA.gov ↗

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