RoVo Mechanical Thrombectomy System— 510(k) K253730

Name: FDA 510(k) clearance K253730
Creator: U.S. Food and Drug Administration
Published: 2026-01-21

Substantially Equivalent

Verge Medical, Inc.

FDA 510(k) clearance K253730 for RoVo Mechanical Thrombectomy System, Substantially Equivalent on 2026-01-21. Applicant: Verge Medical, Inc.. Device class: 2.

Clearance details

Applicant: Verge Medical, Inc.
Product code: Code QEW
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2025-11-24
Decision date: 2026-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Campbell, CA, US

Download summary PDF View on FDA.gov ↗

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K260599 — INDIGO® Aspiration System INDIGO Link2026-04-24
K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK2026-02-05

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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.