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FDA 510(k)

Venous Return Cannulae

K-Number: K250937 · 2026-03-11

ApplicantLivaNova USA, Inc.
Decision Date2026-03-11
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Venous Return Cannulae is the device name listed in this FDA 510(k) record. The listed applicant is LivaNova USA, Inc.. It received FDA 510(k) clearance on 2026-03-11 under 510(k) number K250937. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Venous Return Cannulae?

Venous Return Cannulae is a medical device that received FDA 510(k) clearance on 2026-03-11. The listed applicant is LivaNova USA, Inc.. The 510(k) number is K250937.

When did Venous Return Cannulae receive FDA 510(k) clearance?

Venous Return Cannulae received FDA 510(k) clearance on 2026-03-11, under 510(k) number K250937.

Who is the listed applicant for Venous Return Cannulae?

The FDA 510(k) record lists LivaNova USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venous Return Cannulae?

The FDA product code for Venous Return Cannulae is DWF.

Other records listing LivaNova USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.K253106AngioVac CannulaAngioDynamics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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