Cleared Traditional

COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

K982760 · Gambro Healthcare · Gastroenterology & Urology

Nov 1998

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K982760 is an FDA 510(k) clearance for the COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Gambro Healthcare (Lakewood, US). The FDA issued a Cleared decision on November 4, 1998, 90 days after receiving the submission on August 6, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K982760 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 1998
Decision Date	November 04, 1998
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

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