FDA 510(k)

Low Potassium Dextran Solution with Tris Diluent

K-Number: K153384 · 2016-02-19

ApplicantUnited Therapeutics Corporation

Decision Date2016-02-19

Product CodeKDN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Low Potassium Dextran Solution with Tris Diluent is the device name listed in this FDA 510(k) record. The listed applicant is United Therapeutics Corporation. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K153384. 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 Low Potassium Dextran Solution with Tris Diluent?

Low Potassium Dextran Solution with Tris Diluent is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is United Therapeutics Corporation. The 510(k) number is K153384.

When did Low Potassium Dextran Solution with Tris Diluent receive FDA 510(k) clearance?

Low Potassium Dextran Solution with Tris Diluent received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153384.

Who is the listed applicant for Low Potassium Dextran Solution with Tris Diluent?

The FDA 510(k) record lists United Therapeutics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Low Potassium Dextran Solution with Tris Diluent?

The FDA product code for Low Potassium Dextran Solution with Tris Diluent is KDN.

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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.