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FDA 510(k)

CLIRANS E-SERIES HOLLOW FIBER DIALYZERS

K-Number: K003425 · 2001-02-01

ApplicantTerumo Medical Corp.
Decision Date2001-02-01
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLIRANS E-SERIES HOLLOW FIBER DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2001-02-01 under 510(k) number K003425. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLIRANS E-SERIES HOLLOW FIBER DIALYZERS?

CLIRANS E-SERIES HOLLOW FIBER DIALYZERS is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is Terumo Medical Corp.. The 510(k) number is K003425.

When did CLIRANS E-SERIES HOLLOW FIBER DIALYZERS receive FDA 510(k) clearance?

CLIRANS E-SERIES HOLLOW FIBER DIALYZERS received FDA 510(k) clearance on 2001-02-01, under 510(k) number K003425.

Who is the listed applicant for CLIRANS E-SERIES HOLLOW FIBER DIALYZERS?

The FDA 510(k) record lists Terumo Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLIRANS E-SERIES HOLLOW FIBER DIALYZERS?

The FDA product code for CLIRANS E-SERIES HOLLOW FIBER DIALYZERS is KDI.

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Related Devices (Code: KDI)

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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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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