Cleared Traditional

CAPILLARY FLOW DIALYZERS

K870169 · Travenol Laboratories, S.A. · Gastroenterology & Urology
Apr 1987
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K870169 is an FDA 510(k) clearance for the CAPILLARY FLOW DIALYZERS, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on April 6, 1987, 82 days after receiving the submission on January 14, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K870169 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 1987
Decision Date April 06, 1987
Days to Decision 82 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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