Cleared Special

Versus? Catheter (VS110-9NB)

K260149 · Liquet Medical, Inc. · Cardiovascular

Feb 2026

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K260149 is an FDA 510(k) clearance for the Versus? Catheter (VS110-9NB), 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 February 17, 2026, 28 days after receiving the submission on January 20, 2026. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K260149 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 2026
Decision Date	February 17, 2026
Days to Decision	28 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.