Cleared Traditional

EkoSonic Endovascular Device

K211080 · Boston Scientific · Cardiovascular

Nov 2021

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K211080 is an FDA 510(k) clearance for the EkoSonic Endovascular Device, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on November 19, 2021, 221 days after receiving the submission on April 12, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K211080 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2021
Decision Date	November 19, 2021
Days to Decision	221 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEY — Mechanical Thrombolysis Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.