Venous Return Cannulae— 510(k) K250937

Name: FDA 510(k) clearance K250937
Creator: U.S. Food and Drug Administration
Published: 2026-03-11

Substantially Equivalent

LivaNova USA, Inc.

FDA 510(k) clearance K250937 for Venous Return Cannulae, Substantially Equivalent on 2026-03-11. Applicant: LivaNova USA, Inc.. Device class: 2.

Summary

LivaNova USA's Venous Return Cannulae are filed under DWF, cardiopulmonary bypass vascular catheters, cannulas and tubing. The name is generic, and the record doesn't list sizes or models.

Class II, 21 CFR 870.4210. It was a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.

LivaNova USA filed from Arvada, Colorado. The decision came 348 calendar days after FDA received it (March 28, 2025 to March 11, 2026).

Clearance details

Applicant: LivaNova USA, Inc.
Product code: Product code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2025-03-28
Decision date: 2026-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

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K263596 — DLP Coronary Ostial Cannulae2026-10-29
K263092 — Dual Stage Venous Cannulae2026-10-01
K262052 — Tri Stage Venous Cannulae2026-09-28
K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23

More clearances from LivaNova USA, Inc.

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K250283 — RAP Femoral Venous Cannulae2025-07-10
K233702 — SMARxT Tubing and Connectors2024-08-08

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.