FDA 510(k)

Servator P SALF Solution with THAM

K-Number: K202652 · 2021-08-19

Decision Date2021-08-19

Product CodeKDN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Servator P SALF Solution with THAM is a medical device manufactured by S.A.L.F. Spa. It received FDA 510(k) clearance on 2021-08-19 under approval number K202652. 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 SALF Solution with THAM?

Servator P SALF Solution with THAM is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by S.A.L.F. Spa. The 510(k) number is K202652.

When was Servator P SALF Solution with THAM approved by the FDA?

Servator P SALF Solution with THAM received FDA 510(k) clearance on 2021-08-19, under approval number K202652.

What company makes Servator P SALF Solution with THAM?

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

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

The FDA product code for Servator P SALF Solution with THAM 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 K230193Servator P Plus SALF Solution

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.