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FDA 510(k)

Novalung ultimate kit (US)

K-Number: K232926 · 2024-04-15

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2024-04-15
Product CodeQJZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Novalung ultimate kit (US) is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2024-04-15 under 510(k) number K232926. The device is classified under product code QJZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Novalung ultimate kit (US)?

Novalung ultimate kit (US) is a medical device that received FDA 510(k) clearance on 2024-04-15. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K232926.

When did Novalung ultimate kit (US) receive FDA 510(k) clearance?

Novalung ultimate kit (US) received FDA 510(k) clearance on 2024-04-15, under 510(k) number K232926.

Who is the listed applicant for Novalung ultimate kit (US)?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Novalung ultimate kit (US)?

The FDA product code for Novalung ultimate kit (US) is QJZ.

Related Clinical Trials

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.

NCT07156669Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)NOT_YET_RECRUITING

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Related Devices (Code: QJZ)

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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