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FDA 510(k)

Protek Solo 24 Fr Venous Cannula Set

K-Number: K162214 · 2016-11-30

ApplicantCardiacassist, Inc.
Decision Date2016-11-30
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Protek Solo 24 Fr Venous Cannula Set is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2016-11-30 under approval number K162214. 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 Solo 24 Fr Venous Cannula Set?

Protek Solo 24 Fr Venous Cannula Set is a medical device that received FDA 510(k) clearance on 2016-11-30. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K162214.

When was Protek Solo 24 Fr Venous Cannula Set approved by the FDA?

Protek Solo 24 Fr Venous Cannula Set received FDA 510(k) clearance on 2016-11-30, under approval number K162214.

What company makes Protek Solo 24 Fr Venous Cannula Set?

Protek Solo 24 Fr Venous Cannula Set is manufactured by Cardiacassist, Inc..

What is the FDA product code for Protek Solo 24 Fr Venous Cannula Set?

The FDA product code for Protek Solo 24 Fr Venous Cannula Set is DWF.

Related Clinical Trials

NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

Other Devices by Cardiacassist, Inc.

K160257PROTEK Duo 31 Fr. Veno-Venous Cannula Set K153295TandemLung Oxygenator K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set K181150ProtekDuo Mini Veno-Venous Cannula Set K183623LifeSPARC Pump, LifeSPARC Controller K202751TandemHeart Pump and Escort Controller

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Related Devices (Code: DWF)

K160257PROTEK Duo 31 Fr. Veno-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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