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FDA 510(k)

ProtekDuo Veno-Venous Cannula Sets

K-Number: K232480 · 2023-10-06

ApplicantCardiacassist, Inc.
Decision Date2023-10-06
Product CodePZS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ProtekDuo Veno-Venous Cannula Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) 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. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K232480.

When did ProtekDuo Veno-Venous Cannula Sets receive FDA 510(k) clearance?

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

Who is the listed applicant for ProtekDuo Veno-Venous Cannula Sets?

The FDA 510(k) record lists Cardiacassist, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cardiacassist, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: PZS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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