Cleared Special

EKOS+ Endovascular Device

K220866 · Boston Scientific · Cardiovascular

Apr 2022

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K220866 is an FDA 510(k) clearance for the EKOS+ 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 April 20, 2022, 26 days after receiving the submission on March 25, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K220866 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2022
Decision Date	April 20, 2022
Days to Decision	26 days
Submission Type	Special
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.