FDA 510(k)

EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222

K-Number: K061254 · 2006-06-23

Decision Date2006-06-23

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 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 2006-06-23 under 510(k) number K061254. 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 EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222?

EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K061254.

When did EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 receive FDA 510(k) clearance?

EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 received FDA 510(k) clearance on 2006-06-23, under 510(k) number K061254.

Who is the listed applicant for EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222?

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 EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222?

The FDA product code for EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 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.