Cleared Special

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray

K161504 · Cook Incorporated · Gastroenterology & Urology
Jan 2017
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K161504 is an FDA 510(k) clearance for the Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray, a Catheter, Hemodialysis, Non-implanted (Class II — Special Controls, product code MPB), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on January 6, 2017, 219 days after receiving the submission on June 1, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K161504 FDA.gov
FDA Decision Cleared SEKD
Date Received June 01, 2016
Decision Date January 06, 2017
Days to Decision 219 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MPB — Catheter, Hemodialysis, Non-implanted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

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