Cleared Traditional

RENAL LINK

K990953 · Baxter Healthcare Corp · Gastroenterology & Urology
Jun 1999
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K990953 is an FDA 510(k) clearance for the RENAL LINK, a System, Dialysate Delivery, Semi-automatic, Peritoneal (Class II — Special Controls, product code KPF), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on June 18, 1999, 88 days after receiving the submission on March 22, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K990953 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 1999
Decision Date June 18, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KPF — System, Dialysate Delivery, Semi-automatic, Peritoneal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

Similar Devices — KPF System, Dialysate Delivery, Semi-automatic, Peritoneal

All 12
RENALSOFT
K061515 · Baxter Healthcare Corp · Sep 2006
CYBERREN
K970989 · Cybernius Medical , Ltd. · Jul 1997
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955762 · Fresenius USA, Inc. · Jul 1996
TOTAL CONTAINMENT DEVICE
K913515 · Denco · May 1994
AMICON EQUALINE FLUID BALANCE SYSTEM
K875121 · Amicon, Inc. · Feb 1988
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · Abbott Laboratories · Jan 1988