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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-01-06 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K161504.

When did Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray receive FDA 510(k) clearance?

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

Who is the listed applicant for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

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

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.

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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.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International CorporationK192807Duo-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.K153190Zenysis Short-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.

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