FDA 510(k)

ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX

K-Number: K031827 · 2003-07-02

Decision Date2003-07-02

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Perfusion Systems. It received FDA 510(k) clearance on 2003-07-02 under 510(k) number K031827. 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 ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX?

ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX is a medical device that received FDA 510(k) clearance on 2003-07-02. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K031827.

When did ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX receive FDA 510(k) clearance?

ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX received FDA 510(k) clearance on 2003-07-02, under 510(k) number K031827.

Who is the listed applicant for ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX?

The FDA 510(k) record lists Medtronic Perfusion Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX?

The FDA product code for ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX is DWF.

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Related Devices (Code: DWF)

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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.