FDA Product Code FJI: Dialyzer, Capillary, Hollow Fiber

Cleared Aug 23, 2019

Hemoflow F3 and F4 Dialyzers

K190459

Fresenius Medical Care Renal Therapies Group, LLC

Gastroenterology & Urology · 178d

Cleared Dec 04, 2013

NIPRO PUREFLUX-L HEMODIALYZER

K122952

Nipro Medical Corporation

Gastroenterology & Urology · 435d

Cleared Jun 13, 2001

ULTRACONCENTRATOR SYSTEM

K011148

Interpore Cross Intl.

Gastroenterology & Urology · 58d

Cleared Dec 04, 2000

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

K002761

Fresenius Medical Care North America

Gastroenterology & Urology · 90d

Cleared May 19, 1998

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234

K980658

Baxter Healthcare Corp

Gastroenterology & Urology · 89d

Cleared Dec 19, 1997

CLIRANS T-SERIES HOLLOW FIBER DIALYZERS

K970708

Terumo Medical Corp.

Gastroenterology & Urology · 296d

Cleared Nov 24, 1997

PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER

K963933

Baxter Healthcare Corp

Gastroenterology & Urology · 419d

Cleared Dec 22, 1995

FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER

K952343

National Medical Care, Medical Products Div., Inc.

Gastroenterology & Urology · 217d

Cleared Apr 27, 1995

CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER

K950454

Baxter Healthcare Corp

Gastroenterology & Urology · 83d

Cleared Mar 06, 1995

CLIRANS WET PACK HOLLOW FIBER DIALYZER

K930503

Terumo Medical Corp.

Gastroenterology & Urology · 763d

Cleared Jan 11, 1995

BAXTER CA DIALYZER

K926567

Baxter Healthcare Corp

Gastroenterology & Urology · 741d

Cleared Aug 23, 1994

FRESENIUS HEMOFLOW, VARIOUS MODELS

K926005

Fresenius USA, Inc.

Gastroenterology & Urology · 634d

Cleared Mar 05, 1993

HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R

K914790

National Medical Care, Medical Products Div., Inc.

Gastroenterology & Urology · 499d

Cleared Dec 12, 1990

NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER

K904566

Cobe Laboratories, Inc.

Gastroenterology & Urology · 64d

Cleared Dec 10, 1990

MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ

K905228

Baxter Healthcare Corp

Gastroenterology & Urology · 20d

Cleared Sep 24, 1990

BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.

K903567

Organon Teknika Corp.

Gastroenterology & Urology · 48d

Cleared Jul 27, 1990

GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

K902481

Gambro, Inc.

Gastroenterology & Urology · 52d

Cleared Jul 24, 1989

HOLLOW FIBER DIALYZER FOCUS 70H

K893677

National Medical Care, Medical Products Div., Inc.

Gastroenterology & Urology · 69d

Cleared Jun 09, 1989

CLIRANS HOLLOW FIBER HEMODIALYZER (WET)

K891477

Terumo Medical Corp.

Gastroenterology & Urology · 85d

Cleared May 11, 1989

GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY

K892523

Gambro, Inc.

Gastroenterology & Urology · 30d

Cleared Feb 08, 1989

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER

K890111

Gambro, Inc.

Gastroenterology & Urology · 28d

Cleared Oct 21, 1988

CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100

K883534

Baxter Healthcare Corp

Gastroenterology & Urology · 64d

Cleared Oct 21, 1988

CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170

K883644

Baxter Healthcare Corp

Gastroenterology & Urology · 57d

Cleared Sep 29, 1988

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER

K883589

Gambro, Inc.

Gastroenterology & Urology · 38d