FDA 510(k)

Custodiol HTK Solution

K-Number: K192408 · 2020-04-24

Decision Date2020-04-24

Product CodeKDL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Custodiol HTK Solution is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Franz Kohler Chemie GmbH. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K192408. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Custodiol HTK Solution?

Custodiol HTK Solution is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Dr. Franz Kohler Chemie GmbH. The 510(k) number is K192408.

When did Custodiol HTK Solution receive FDA 510(k) clearance?

Custodiol HTK Solution received FDA 510(k) clearance on 2020-04-24, under 510(k) number K192408.

Who is the listed applicant for Custodiol HTK Solution?

The FDA 510(k) record lists Dr. Franz Kohler Chemie GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Custodiol HTK Solution?

The FDA product code for Custodiol HTK Solution is KDL.

Related Devices (Code: KDL)

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.

K241239OrganProtex HTK SolutionBridge TO Life, Ltd.K221387BEL-GEN Cold Storage SolutionInstitut Georges Lopez K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez K211842Servator M SALF SolutionS.A.L.F. Spa K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa

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.