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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Venous Return Cannulae

Manufacturer

LivaNova USA, Inc.

Date Cleared

2026-03-11

(348 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

K943934,K890980,K861496,K994209,K120988

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Venous Return Cannula is indicated for use in drainage of the superior and inferior vena cava during cardiopulmonary bypass surgery for up to six hours.

Device Description

AI/ML Overview

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