Cleared Traditional

DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM

K970446 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology

Jun 1997

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K970446 is an FDA 510(k) clearance for the DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS 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 June 2, 1997, 117 days after receiving the submission on February 5, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K970446 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 1997
Decision Date	June 02, 1997
Days to Decision	117 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