ClotTriever Thrombectomy System— 510(k) K210190

Name: FDA 510(k) clearance K210190
Creator: U.S. Food and Drug Administration
Published: 2021-02-23

Substantially Equivalent

Irani Medical, Inc.

FDA 510(k) clearance K210190 for ClotTriever Thrombectomy System, Substantially Equivalent on 2021-02-23. Applicant: Irani Medical, Inc.. Device class: 2.

Clearance details

Applicant: Irani Medical, Inc.
Product code: Code QEW
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2021-01-25
Decision date: 2021-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEW

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K253419 — Triever Duo Catheter2026-09-18
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

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.