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FDA 510(k)

CUSTODIOL

K-Number: K032794 · 2004-04-05

ApplicantDr. Franz Kohler Chemie GmbH
Decision Date2004-04-05
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CUSTODIOL 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 2004-04-05 under 510(k) number K032794. The device is classified under product code MSB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTODIOL?

CUSTODIOL is a medical device that received FDA 510(k) clearance on 2004-04-05. The listed applicant is Dr. Franz Kohler Chemie GmbH. The 510(k) number is K032794.

When did CUSTODIOL receive FDA 510(k) clearance?

CUSTODIOL received FDA 510(k) clearance on 2004-04-05, under 510(k) number K032794.

Who is the listed applicant for CUSTODIOL?

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?

The FDA product code for CUSTODIOL is MSB.

Related Clinical Trials

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.

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Other records listing Dr. Franz Kohler Chemie GmbH 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.

K192408Custodiol HTK SolutionK043461CUSTODIOLK020924CUSTODIOL HTK SOLUTIONK992209CUSTODIOL

Related Devices (Code: MSB)

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.

K261913X°Port Heart Preservation SystemTraferox Technologies, Inc.K222535OCS Lung Donor Flush SetTransMedics, Inc.K211314OCS Lung SolutionTransMedics, Inc.K190063Servator C SALF SolutionS.A.L.F. SpaK182735Paragonix SherpaPak Cardiac Transport SystemParagonix TechnologiesK180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc.

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.

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