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FDA 510(k)

Acute Dual Lumen Hemodialysis Catheter

K-Number: K200426 · 2020-12-24

ApplicantHealth Line International Corporation
Decision Date2020-12-24
Product CodeMPB
Advisory CommitteeGU
DecisionUnknown

Device Summary

Acute Dual Lumen Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2020-12-24 under 510(k) number K200426. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Acute Dual Lumen Hemodialysis Catheter?

Acute Dual Lumen Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2020-12-24. The listed applicant is Health Line International Corporation. The 510(k) number is K200426.

When did Acute Dual Lumen Hemodialysis Catheter receive FDA 510(k) clearance?

Acute Dual Lumen Hemodialysis Catheter received FDA 510(k) clearance on 2020-12-24, under 510(k) number K200426.

Who is the listed applicant for Acute Dual Lumen Hemodialysis Catheter?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acute Dual Lumen Hemodialysis Catheter?

The FDA product code for Acute Dual Lumen Hemodialysis Catheter is MPB.

Other records listing Health Line International Corporation 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.

K261950Health Line Tearaway IntroducerK222170Power Acute Triple Lumen Hemodialysis CatheterK200263Health Line CT Midline CatheterK192533Health Line CT CVCK160448ARTLINE

Related Devices (Code: MPB)

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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.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, LLCK163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook IncorporatedK153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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