FDA 510(k)

Zenysis Short-Term Dialysis Catheter

K-Number: K153190 · 2016-01-05

Decision Date2016-01-05

Product CodeMPB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Zenysis Short-Term Dialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K153190. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zenysis Short-Term Dialysis Catheter?

Zenysis Short-Term Dialysis Catheter is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K153190.

When did Zenysis Short-Term Dialysis Catheter receive FDA 510(k) clearance?

Zenysis Short-Term Dialysis Catheter received FDA 510(k) clearance on 2016-01-05, under 510(k) number K153190.

Who is the listed applicant for Zenysis Short-Term Dialysis Catheter?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenysis Short-Term Dialysis Catheter?

The FDA product code for Zenysis Short-Term Dialysis Catheter is MPB.

Related Clinical Trials

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Other records listing C.R. Bard, Inc. as applicant

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Related Devices (Code: MPB)

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC K163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook 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.