Cleared Traditional

Versus? Catheter (VS110-8B)

K241851 · Liquet Medical, Inc. · Cardiovascular

Nov 2024

Decision

151d

Days

Class 2

Risk

About This 510(k) Submission

K241851 is an FDA 510(k) clearance for the Versus? Catheter (VS110-8B), a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by Liquet Medical, Inc. (Glen Allen, US). The FDA issued a Cleared decision on November 25, 2024, 151 days after receiving the submission on June 27, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K241851 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2024
Decision Date	November 25, 2024
Days to Decision	151 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.