Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RENACLEAR DIALYZER CLEANING SYSTEM

K-Number: K991851 · 1999-08-30

ApplicantMinntech Corp.
Decision Date1999-08-30
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENACLEAR DIALYZER CLEANING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1999-08-30 under 510(k) number K991851. 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 RENACLEAR DIALYZER CLEANING SYSTEM?

RENACLEAR DIALYZER CLEANING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-30. The listed applicant is Minntech Corp.. The 510(k) number is K991851.

When did RENACLEAR DIALYZER CLEANING SYSTEM receive FDA 510(k) clearance?

RENACLEAR DIALYZER CLEANING SYSTEM received FDA 510(k) clearance on 1999-08-30, under 510(k) number K991851.

Who is the listed applicant for RENACLEAR DIALYZER CLEANING SYSTEM?

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

What is the FDA product code for RENACLEAR DIALYZER CLEANING SYSTEM?

The FDA product code for RENACLEAR DIALYZER CLEANING SYSTEM is LIF.

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 Minntech Corp. 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.

K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

View all 33 devices →

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST 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 Incorporated

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.

↑