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)— 510(k) K250013

Name: FDA 510(k) clearance K250013
Creator: U.S. Food and Drug Administration
Published: 2025-03-24

Substantially Equivalent

Control Medical Technology, Inc. / Dba Ventiv Scientific

FDA 510(k) clearance K250013 for 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), Substantially Equivalent on 2025-03-24. Applicant: Control Medical Technology, Inc. / Dba Ventiv Scientific. Device class: 2.

Clearance details

Applicant: Control Medical Technology, Inc. / Dba Ventiv Scientific
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2025-01-02
Decision date: 2025-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEZ

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K254035 — Mayumi Thrombectomy System2026-09-03
K261105 — Powered Aventus Thrombectomy System2026-07-27
K262030 — Aventus Thrombectomy System2026-07-15
K253589 — Liberant RX Aspiration Catheter2026-04-23
K254208 — FLOWRUNNER Aspiration System2026-03-20

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.