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FDA 510(k)

CLIRANS TE12 HOLLOW FIBER DIALYZER

K-Number: K812498 · 1981-09-29

ApplicantTerumo Medical Corp.
Decision Date1981-09-29
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLIRANS TE12 HOLLOW FIBER DIALYZER 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 1981-09-29 under 510(k) number K812498. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLIRANS TE12 HOLLOW FIBER DIALYZER?

CLIRANS TE12 HOLLOW FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Terumo Medical Corp.. The 510(k) number is K812498.

When did CLIRANS TE12 HOLLOW FIBER DIALYZER receive FDA 510(k) clearance?

CLIRANS TE12 HOLLOW FIBER DIALYZER received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812498.

Who is the listed applicant for CLIRANS TE12 HOLLOW FIBER DIALYZER?

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 TE12 HOLLOW FIBER DIALYZER?

The FDA product code for CLIRANS TE12 HOLLOW FIBER DIALYZER is KOC.

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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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