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FDA 510(k)

ProtekDuo Veno-Venous Cannula Sets

K-Number: K232480 · 2023-10-06

Decision Date2023-10-06
Product CodePZS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ProtekDuo Veno-Venous Cannula Sets is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2023-10-06 under approval number K232480. The device is classified under product code PZS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProtekDuo Veno-Venous Cannula Sets?

ProtekDuo Veno-Venous Cannula Sets is a medical device that received FDA 510(k) clearance on 2023-10-06. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K232480.

When was ProtekDuo Veno-Venous Cannula Sets approved by the FDA?

ProtekDuo Veno-Venous Cannula Sets received FDA 510(k) clearance on 2023-10-06, under approval number K232480.

What company makes ProtekDuo Veno-Venous Cannula Sets?

ProtekDuo Veno-Venous Cannula Sets is manufactured by Cardiacassist, Inc..

What is the FDA product code for ProtekDuo Veno-Venous Cannula Sets?

The FDA product code for ProtekDuo Veno-Venous Cannula Sets is PZS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.