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FDA 510(k)

Dual Stage Venous Cannulae

K-Number: K253671 · 2026-01-30

ApplicantSorin Group Italia S.R.L.
Decision Date2026-01-30
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Dual Stage Venous Cannulae is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K253671. 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 Dual Stage Venous Cannulae?

Dual Stage Venous Cannulae is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K253671.

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

Dual Stage Venous Cannulae received FDA 510(k) clearance on 2026-01-30, under 510(k) number K253671.

Who is the listed applicant for Dual Stage Venous Cannulae?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual Stage Venous Cannulae?

The FDA product code for Dual Stage Venous Cannulae is DWF.

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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.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253998Clearview Intracoronary ShuntsMedtronic, Inc.K253106AngioVac CannulaAngioDynamics, Inc.

Official Source

View on FDA Database →

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

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