FDA 510(k)

MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES

K-Number: K033264 · 2003-10-31

Decision Date2003-10-31

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES 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 2003-10-31 under 510(k) number K033264. 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 MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES?

MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K033264.

When did MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES receive FDA 510(k) clearance?

MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES received FDA 510(k) clearance on 2003-10-31, under 510(k) number K033264.

Who is the listed applicant for MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES?

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 MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES?

The FDA product code for MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES 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.