Cleared Traditional

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM

K964922 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology

May 1997

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K964922 is an FDA 510(k) clearance for the DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Althin Medical AB an Affiliate of Baxter Intl (Portland, US). The FDA issued a Cleared decision on May 21, 1997, 163 days after receiving the submission on December 9, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K964922 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 1996
Decision Date	May 21, 1997
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

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