Cleared Traditional

HIGH EFFICIENCY HEMODIALYSIS SYSTEM

K861776 · Travenol Laboratories, S.A. · Gastroenterology & Urology

Jun 1986

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K861776 is an FDA 510(k) clearance for the HIGH EFFICIENCY HEMODIALYSIS SYSTEM, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on June 19, 1986, 42 days after receiving the submission on May 8, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K861776 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 1986
Decision Date	June 19, 1986
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860