Dialyzer, Capillary, Hollow Fiber

FDA product code FJI · 131 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5820
Review panel: GU
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1976-10-15 – 2019-08-23

FJI 2019-08-23

Hemoflow F3 and F4 Dialyzers

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K190459

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FJI 2013-12-04

NIPRO PUREFLUX-L HEMODIALYZER

Applicant Nipro Medical Corporation

K number K122952

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FJI 2005-05-27

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

Applicant Gambro Renal Products

K number K043342

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FJI 2001-11-28

DISPOSABLE STORAGE CAP

Applicant Molded Products, Inc.

K number K010366

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FJI 2001-06-13

ULTRACONCENTRATOR SYSTEM

Applicant Interpore Cross Intl.

K number K011148

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FJI 2000-12-04

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

Applicant Fresenius Medical Care North America

K number K002761

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FJI 2000-04-17

IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS

Applicant Idemsa

K number K991908

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FJI 1999-09-24

A-15 HEMODIALYZER

Applicant Althin Medical AB

K number K992594

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FJI 1999-09-23

A-18 HEMODIALYZER

Applicant Althin Medical AB

K number K992565

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FJI 1999-07-29

ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X

Applicant Asahi Medical Co., Ltd.

K number K991512

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FJI 1999-04-19

DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111

Applicant Dynamic Technology Corp.

K number K990159

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FJI 1998-12-29

CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER

Applicant Haidylena Medical Egypt

K number K982337

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FJI 1998-12-11

ULTRACON ULTRAFILTRATOR

Applicant Interpore Intl.

K number K981253

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FJI 1998-05-19

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

Applicant Baxter Healthcare Corp

K number K980658

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FJI 1998-02-27

ULTRACON ULTRAFILTRATOR

Applicant Quantic Biomedical, Inc.

K number K971710

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FJI 1997-12-19

DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES

Applicant Dynamic Technology Corp.

K number K973291

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FJI 1997-12-19

CLIRANS T-SERIES HOLLOW FIBER DIALYZERS

Applicant Terumo Medical Corp.

K number K970708

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FJI 1997-11-24

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

Applicant Baxter Healthcare Corp

K number K963933

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FJI 1996-12-27

ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K962309

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FJI 1996-09-12

BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL

Applicant Dayspring Medical, Inc.

K number K961039

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FJI 1996-06-11

BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC

Applicant Dayspring Medical, Inc.

K number K961040

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FJI 1996-06-10

BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL

Applicant Dayspring Medical, Inc.

K number K961026

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FJI 1996-01-29

COBE CENTRYSYSTEM CS 200 DIALYZER

Applicant Cobe Renal Care, Inc.

K number K944436

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FJI 1995-12-22

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

Applicant National Medical Care, Medical Products Div., Inc.

K number K952343

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FJI 1995-11-30

PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS

Applicant Reprocessing Products Corp

K number K950602

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FJI 1995-09-08

GAMBRO LUNDIA 94-500 DIALYZER

Applicant Cobe Renal Care, Inc.

K number K945746

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FJI 1995-05-25

MCA(TM) 180 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945622

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FJI 1995-05-19

FILTRYZER(TM)

Applicant Toray Industries (America), Inc.

K number K935471

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FJI 1995-05-18

155 SCE(TM) HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945631

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FJI 1995-05-18

MCA(TM) 160 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945624

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FJI 1995-05-18

MCA(TM) 130 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945623

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FJI 1995-05-12

COBE CENTRYSYSTEM CS500 DIALYZER

Applicant C.G.H. Medical, Inc.

K number K941708

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FJI 1995-05-04

FILTRYZER

Applicant Toray Industries (America), Inc.

K number K940910

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FJI 1995-04-27

CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER

Applicant Baxter Healthcare Corp

K number K950454

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FJI 1995-03-06

CLIRANS WET PACK HOLLOW FIBER DIALYZER

Applicant Terumo Medical Corp.

K number K930503

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FJI 1995-02-13

MCA 200 HEMPDIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K926372

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FJI 1995-01-11

BAXTER CA DIALYZER

Applicant Baxter Healthcare Corp

K number K926567

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FJI 1994-08-23

FRESENIUS HEMOFLOW, VARIOUS MODELS

Applicant Fresenius USA, Inc.

K number K926005

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FJI 1993-03-05

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

Applicant National Medical Care, Medical Products Div., Inc.

K number K914790

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FJI 1991-05-23

ALDETECT

Applicant Pochemco, Inc.

K number K905779

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FJI 1990-12-12

NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER

Applicant Cobe Laboratories, Inc.

K number K904566

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FJI 1990-12-10

MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ

Applicant Baxter Healthcare Corp

K number K905228

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FJI 1990-09-24

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

Applicant Organon Teknika Corp.

K number K903567

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FJI 1990-07-27

GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

Applicant Gambro, Inc.

K number K902481

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FJI 1989-07-24

HOLLOW FIBER DIALYZER FOCUS 70H

Applicant National Medical Care, Medical Products Div., Inc.

K number K893677

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FJI 1989-06-09

CLIRANS HOLLOW FIBER HEMODIALYZER (WET)

Applicant Terumo Medical Corp.

K number K891477

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FJI 1989-05-18

MODIFIED AM-SERIES DIALYZERS

Applicant Asahi Medical Co., Ltd.

K number K892375

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FJI 1989-05-18

NEW AM-SERIES DIALYZERS

Applicant Asahi Medical Co., Ltd.

K number K892374

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FJI 1989-05-11

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

Applicant Gambro, Inc.

K number K892523

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FJI 1989-03-17

TORAY FILTRYZER DIALYZERS

Applicant Toray Industries (America), Inc.

K number K884339

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FJI 1989-02-08

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER

Applicant Gambro, Inc.

K number K890111

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FJI 1989-01-31

RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS

Applicant Kawasumi Laboratories Co., Ltd.

K number K883748

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FJI 1988-10-21

CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170

Applicant Baxter Healthcare Corp

K number K883644

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FJI 1988-10-21

CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100

Applicant Baxter Healthcare Corp

K number K883534

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FJI 1988-09-29

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER

Applicant Gambro, Inc.

K number K883589

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FJI 1988-09-15

COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS

Applicant Cobe Laboratories, Inc.

K number K881811

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FJI 1988-08-12

MODIFIED TORAY FILTRYZER DIALYZERS

Applicant Toray Industries (America), Inc.

K number K882158

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FJI 1988-07-22

ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA

Applicant Baxter Healthcare Corp

K number K882680

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FJI 1988-06-28

BIO*NEPHROSS I.Q. ANDANTE

Applicant Organon Teknika Corp.

K number K882339

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FJI 1988-06-28

NEPHROSS I.Q. MODERATO

Applicant Organon Teknika Corp.

K number K882215

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FJI 1988-06-28

NEPHROSS I.Q. ALLEGO

Applicant Organon Teknika Corp.

K number K882213

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FJI 1988-02-19

GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS

Applicant Gambro, Inc.

K number K880084

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FJI 1988-02-19

FRESENIUS HEMOFLOW F3, F4, F5, F7

Applicant Seratronics, Inc.

K number K874872

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FJI 1988-01-29

CAPILLARY FLOW DIALYZERS

Applicant Baxter Healthcare Corp

K number K874728

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FJI 1988-01-29

NEPHROSS I.Q. ANDANTE

Applicant Organon Teknika Corp.

K number K874549

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FJI 1988-01-27

GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS

Applicant Gambro, Inc.

K number K880083

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FJI 1987-06-12

CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15

Applicant Travenol Laboratories, S.A.

K number K871471

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FJI 1987-05-29

HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H

Applicant National Medical Care, Medical Products Div., Inc.

K number K871236

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FJI 1987-05-01

FRESENIUS HEMOFLOW F6 AND F8

Applicant Seratronics, Inc.

K number K870725

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FJI 1987-04-06

CAPILLARY FLOW DIALYZERS

Applicant Travenol Laboratories, S.A.

K number K870169

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FJI 1987-03-27

COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS

Applicant Cobe Laboratories, Inc.

K number K864831

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FJI 1987-03-27

CAPILLARY FLOW HOLLOW FIBER DIALYZERS

Applicant National Medical Care, Medical Products Div., Inc.

K number K863044

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FJI 1986-09-25

DISSCAP 80E, 110E, 140E, 160E

Applicant Hospal Medical Corp.

K number K863592

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FJI 1986-07-22

TORAY FILTRYZER DIALYZER, B1-2.0.

Applicant National Medical Care, Medical Products Div., Inc.

K number K862693

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FJI 1986-07-10

ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER

Applicant National Medical Care, Medical Products Div., Inc.

K number K861916

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FJI 1986-07-10

ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5

Applicant National Medical Care, Medical Products Div., Inc.

K number K861537

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FJI 1986-07-10

ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7

Applicant National Medical Care, Medical Products Div., Inc.

K number K861536

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FJI 1986-01-21

ASAHI AM SERIES DIALYZERS

Applicant Advocacy International, Ltd.

K number K855212

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FJI 1985-12-13

CLIRANS TAF HOLLOW FIBER DIALYZER

Applicant Terumo Medical Corp.

K number K854280

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FJI 1985-12-02

MODIFIED AM-SERIES DIALYZERS

Applicant Asahi Medical Co., Ltd.

K number K854575

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FJI 1985-09-11