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FDA 510(k)

CLEARFLUX DIALYZER REPROCESSING SYSTEM

K-Number: K091360 · 2010-11-03

ApplicantNovaflux Technologies
Decision Date2010-11-03
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLEARFLUX DIALYZER REPROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Novaflux Technologies. It received FDA 510(k) clearance on 2010-11-03 under 510(k) number K091360. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARFLUX DIALYZER REPROCESSING SYSTEM?

CLEARFLUX DIALYZER REPROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-03. The listed applicant is Novaflux Technologies. The 510(k) number is K091360.

When did CLEARFLUX DIALYZER REPROCESSING SYSTEM receive FDA 510(k) clearance?

CLEARFLUX DIALYZER REPROCESSING SYSTEM received FDA 510(k) clearance on 2010-11-03, under 510(k) number K091360.

Who is the listed applicant for CLEARFLUX DIALYZER REPROCESSING SYSTEM?

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

What is the FDA product code for CLEARFLUX DIALYZER REPROCESSING SYSTEM?

The FDA product code for CLEARFLUX DIALYZER REPROCESSING SYSTEM is LIF.

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Related Devices (Code: LIF)

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.

K043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International IncorporatedK992016AMUKIN DAmuchina Intl., 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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