Cleared Traditional

CLIRANS TH10 HOLLOW FIBER DIALYZER

K802441 · Terumo America, Inc. · Gastroenterology & Urology
Dec 1980
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K802441 is an FDA 510(k) clearance for the CLIRANS TH10 HOLLOW FIBER DIALYZER, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980, 72 days after receiving the submission on October 7, 1980. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K802441 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1980
Decision Date December 18, 1980
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FJI — Dialyzer, Capillary, Hollow Fiber
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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