Cleared Traditional

PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015

K990643 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology

Dec 1999

Decision

284d

Days

Class 2

Risk

About This 510(k) Submission

K990643 is an FDA 510(k) clearance for the PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015, 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 (Miami Lakes, US). The FDA issued a Cleared decision on December 7, 1999, 284 days after receiving the submission on February 26, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K990643 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 1999
Decision Date	December 07, 1999
Days to Decision	284 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