FDA 510(k)

Servator P Plus SALF Solution

K-Number: K230193 · 2023-09-21

Decision Date2023-09-21

Product CodeKDN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Servator P Plus SALF Solution is a medical device manufactured by S.A.L.F. Spa. It received FDA 510(k) clearance on 2023-09-21 under approval 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. It is manufactured by S.A.L.F. Spa. The 510(k) number is K230193.

When was Servator P Plus SALF Solution approved by the FDA?

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

What company makes Servator P Plus SALF Solution?

Servator P Plus SALF Solution is manufactured by S.A.L.F. Spa.

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 Devices by S.A.L.F. Spa

K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags K180481Servator B SALF Solution K190063Servator C SALF Solution K211842Servator M SALF Solution K202652Servator P SALF Solution with THAM

Related Devices (Code: KDN)

K153384Low Potassium Dextran Solution with Tris DiluentUnited Therapeutics Corporation K180481Servator B SALF SolutionS.A.L.F. Spa K170826Perfadex PlusXvivo Perfusion AB K191440Paragonix SherpaPak Pancreas Transport SystemParagonix Technologies K191006EasiSlushBridge TO Life, Ltd. K201048SherpaPak Pediatric Liver Transport SystemParagonix Technologies

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.