ROVO Mechanical Thrombectomy Device— 510(k) K220780

Name: FDA 510(k) clearance K220780
Creator: U.S. Food and Drug Administration
Published: 2023-03-31

Substantially Equivalent

2mg, Inc.

FDA 510(k) clearance K220780 for ROVO Mechanical Thrombectomy Device, Substantially Equivalent on 2023-03-31. Applicant: 2mg, Inc.. Device class: 2.

Clearance details

Applicant: 2mg, Inc.
Product code: Code QEW
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2022-03-17
Decision date: 2023-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suttons Bay, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEW

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K261800 — Helo Max Thrombectomy System (HEL2090)2026-09-03
K262538 — Artix MT; Artix Thin-Walled Sheath2026-08-21
K261523 — Vertex Thrombectomy System2026-08-04
K260599 — INDIGO® Aspiration System INDIGO Link2026-04-24
K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK2026-02-05

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.