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FDA 510(k)

PROTEK Duo 31 Fr. Veno-Venous Cannula Set

K-Number: K160257 · 2016-03-04

ApplicantCardiacassist, Inc.
Decision Date2016-03-04
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROTEK Duo 31 Fr. Veno-Venous Cannula Set is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2016-03-04 under approval number K160257. 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 PROTEK Duo 31 Fr. Veno-Venous Cannula Set?

PROTEK Duo 31 Fr. Veno-Venous Cannula Set is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K160257.

When was PROTEK Duo 31 Fr. Veno-Venous Cannula Set approved by the FDA?

PROTEK Duo 31 Fr. Veno-Venous Cannula Set received FDA 510(k) clearance on 2016-03-04, under approval number K160257.

What company makes PROTEK Duo 31 Fr. Veno-Venous Cannula Set?

PROTEK Duo 31 Fr. Veno-Venous Cannula Set is manufactured by Cardiacassist, Inc..

What is the FDA product code for PROTEK Duo 31 Fr. Veno-Venous Cannula Set?

The FDA product code for PROTEK Duo 31 Fr. Veno-Venous Cannula Set is DWF.

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Related Devices (Code: DWF)

K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc. K153598Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. K171979Tubing PackMedtronic, Inc. K170488Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 FrSurge Cardiovascular K162215Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L. K171308Tubing PackMedtronic, 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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