RAP Femoral Venous Cannulae— 510(k) K250283

Name: FDA 510(k) clearance K250283
Creator: U.S. Food and Drug Administration
Published: 2025-07-10

Substantially Equivalent

LivaNova USA, Inc.

FDA 510(k) clearance K250283 for RAP Femoral Venous Cannulae, Substantially Equivalent on 2025-07-10. Applicant: LivaNova USA, Inc.. Device class: 2.

Clearance details

Applicant: LivaNova USA, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2025-01-31
Decision date: 2025-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWF

view all

K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
K250937 — Venous Return Cannulae2026-03-11
K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23
K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
K253671 — Dual Stage Venous Cannulae2026-01-30

More clearances from LivaNova USA, Inc.

view all

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.