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FDA 510(k)

CUSTODIOL

K-Number: K043461 · 2005-02-28

ApplicantDr. Franz Kohler Chemie GmbH
Decision Date2005-02-28
Product CodeKDL
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 2005-02-28 under 510(k) number K043461. 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?

CUSTODIOL is a medical device that received FDA 510(k) clearance on 2005-02-28. The listed applicant is Dr. Franz Kohler Chemie GmbH. The 510(k) number is K043461.

When did CUSTODIOL receive FDA 510(k) clearance?

CUSTODIOL received FDA 510(k) clearance on 2005-02-28, under 510(k) number K043461.

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 KDL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SolutionK032794CUSTODIOLK020924CUSTODIOL HTK SOLUTIONK992209CUSTODIOL

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.K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges LopezK221387BEL-GEN Cold Storage SolutionInstitut Georges LopezK211842Servator M SALF SolutionS.A.L.F. SpaK192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbHK170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa

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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