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FDA 510(k)

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray

K-Number: K161504 · 2017-01-06

ApplicantCook Incorporated
Decision Date2017-01-06
Product CodeMPB
Advisory CommitteeGU
DecisionUnknown

Device Summary

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-01-06 under approval number K161504. 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 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Cook Incorporated. The 510(k) number is K161504.

When was Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray approved by the FDA?

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray received FDA 510(k) clearance on 2017-01-06, under approval number K161504.

What company makes Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is manufactured by Cook Incorporated.

What is the FDA product code for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

The FDA product code for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is MPB.

Related Clinical Trials

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Other Devices by Cook Incorporated

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Related Devices (Code: MPB)

K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. K163458Zenysis Short-Term Dialysis CatheterC.R. Bard, 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 K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, 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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