FDA 510(k)

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter

K-Number: K151967 · 2016-04-04

Decision Date2016-04-04

Product CodeMSD

Advisory CommitteeGU

DecisionUnknown

Device Summary

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K151967. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter?

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K151967.

When did Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter receive FDA 510(k) clearance?

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter received FDA 510(k) clearance on 2016-04-04, under 510(k) number K151967.

Who is the listed applicant for Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter?

The FDA product code for Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter is MSD.

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.

NCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITING NCT03311451C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.ACTIVE_NOT_RECRUITING NCT04540302The Merit WRAPSODY AV Access Efficacy Study (WAVE)COMPLETED NCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITING NCT06153667Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)RECRUITING NCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITING

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Related Devices (Code: MSD)

K241581Hemodialysis CatheterHaolang Medical USA Corporation K210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, 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.