Cleared Special

VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)

K250013 · Control Medical Technology, Inc. / Dba Ventiv Scientific · Cardiovascular

Mar 2025

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K250013 is an FDA 510(k) clearance for the VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP), a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Control Medical Technology, Inc. / Dba Ventiv Scientific (Salt Lake City, US). The FDA issued a Cleared decision on March 24, 2025, 81 days after receiving the submission on January 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K250013 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2025
Decision Date	March 24, 2025
Days to Decision	81 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEZ — Aspiration Thrombectomy Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.