Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Servator P Plus SALF Solution

K-Number: K230193 · 2023-09-21

ApplicantS.A.L.F. Spa
Decision Date2023-09-21
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Servator P Plus SALF Solution is the device name listed in this FDA 510(k) record. The listed applicant is S.A.L.F. Spa. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K230193. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Servator P Plus SALF Solution?

Servator P Plus SALF Solution is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is S.A.L.F. Spa. The 510(k) number is K230193.

When did Servator P Plus SALF Solution receive FDA 510(k) clearance?

Servator P Plus SALF Solution received FDA 510(k) clearance on 2023-09-21, under 510(k) number K230193.

Who is the listed applicant for Servator P Plus SALF Solution?

The FDA 510(k) record lists S.A.L.F. Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Servator P Plus SALF Solution?

The FDA product code for Servator P Plus SALF Solution is KDN.

Other records listing S.A.L.F. Spa 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.

K211842Servator M SALF SolutionK202652Servator P SALF Solution with THAMK190063Servator C SALF SolutionK180481Servator B SALF SolutionK170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags

Related Devices (Code: KDN)

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.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

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.

↑