Cleared Traditional

EkoSonic Endovascular Device, EKOS+ Endovascular Device

K213422 · Boston Scientific Corporation · Cardiovascular

Dec 2021

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K213422 is an FDA 510(k) clearance for the EkoSonic Endovascular Device, EKOS+ Endovascular Device, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by Boston Scientific Corporation (Maple Grove Hennepin, US). The FDA issued a Cleared decision on December 14, 2021, 55 days after receiving the submission on October 20, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K213422 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 2021
Decision Date	December 14, 2021
Days to Decision	55 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.