Cleared Traditional

K070222 - FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
(FDA 510(k) Clearance)

K070222 · Fresenius Medical Care North America · Gastroenterology & Urology

Apr 2007

Decision

90d

Days

Class 2

Risk

K070222 is an FDA 510(k) clearance for the FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius Medical Care North America (Waltham,, US). The FDA issued a Cleared decision on April 24, 2007, 90 days after receiving the submission on January 24, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K070222 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2007
Decision Date	April 24, 2007
Days to Decision	90 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