System, Dialysate Delivery, Central Multiple Patient

FDA product code FKQ · 61 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: 1976-12-06 – 2006-06-09

FKQ 2006-06-09

DIACAP ULTRA DIALYSIS FLUID FILTER

Applicant B. Braun Medizintechnologie GmbH

K number K052764

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FKQ 1989-07-24

TWO TANK DISSOLUTION MODULE

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

K number K893612

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FKQ 1988-04-27

MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM

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

K number K874084

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FKQ 1987-10-09

KAWASUMI A.V. FISTULA SET

Applicant Kawasumi Laboratories Co., Ltd.

K number K873421

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FKQ 1987-07-08

ACID FUCHSIN SOLUTIONS

Applicant D.R.G. Scientific Industries

K number K870889

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FKQ 1987-06-09

ACTRIL FOR KIDNEY MACHINE DISINFECTANT

Applicant Renal Systems, Inc.

K number K861730

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FKQ 1987-01-13

FOUR TANK DISSOLUTION MODULE

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

K number K864635

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FKQ 1986-09-09

DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM

Applicant Cd Medical, Inc.

K number K862304

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FKQ 1986-07-10

MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445

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

K number K861472

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FKQ 1986-05-13

AMUCHINA/DIALYZER DISINFECTANT

Applicant Amuchina Intl., Inc.

K number K852359

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FKQ 1986-03-04

HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS

Applicant Breem Laboratories

K number K860336

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FKQ 1986-03-04

HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES

Applicant Renal Hygienics

K number K860297

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FKQ 1986-03-04

HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES

Applicant Physicians Surgeons Purchasing Group

K number K860296

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FKQ 1986-01-08

HEMODIALYSIS CONCENTRATE

Applicant Dana Laboratories

K number K854391

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FKQ 1985-09-10

RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT

Applicant Mesa Medical, Inc.

K number K852749

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FKQ 1985-07-26

NATURALYTE BICARBONATE CONCENTRATE-DRY PACK

Applicant Erika, Inc.

K number K852310

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FKQ 1985-05-17

ALCIDE REN NEW-D

Applicant Alcide Corp.

K number K844734

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FKQ 1985-04-02

MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT

Applicant Medicorp, Inc.

K number K844850

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FKQ 1985-02-15

FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD

Applicant Seratronics, Inc.

K number K844750

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FKQ 1985-02-14

FRESENIUS HAEMODIALYSIS ;MACHINE A1008

Applicant Seratronics, Inc.

K number K844641

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FKQ 1985-01-22

NEPHROSS ALLEGRO H.F.

Applicant Organon Teknika Corp.

K number K844748

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FKQ 1985-01-16

ST FAMILY OF HOLLOW FIBER DIALYZERS

Applicant Travenol Laboratories, S.A.

K number K844756

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FKQ 1985-01-07

DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD

Applicant Renal Systems, Inc.

K number K843963

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FKQ 1984-11-16

UNILYTE A

Applicant Medical Enterprises, Ltd.

K number K843623

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FKQ 1984-10-02

HEMODIAL CONCENTRATE MIXING APPARATUS

Applicant Lmf Medical Research & Manufacturing, Inc.

K number K842225

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FKQ 1984-09-10

FORMACLEAR- & MULTIPLE

Applicant Rna Medical Corp.

K number K842131

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FKQ 1984-07-31

PACKETS FOR THE PREP OF DIALYSATES &

Applicant Organon Teknika Corp.

K number K842154

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FKQ 1984-07-31

MONOXYCHLOROSENE WAREXIN

Applicant Guardian Chemical

K number K834455

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FKQ 1984-07-26

HEMODIALYSIS BATH CONCENTRATE SOLUTION

Applicant Pharmaceutical Development Systems

K number K842058

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FKQ 1984-06-28

DIALYSATE ADDITIVES

Applicant Dialysis Products, Inc.

K number K842294

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FKQ 1984-05-22

CONCENTRATE CONDUCTIVITY METER

Applicant Renal Systems, Inc.

K number K841543

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FKQ 1984-05-02

RENAPAK CONCENTRATE MIXING SYS.

Applicant Renal Systems, Inc.

K number K840182

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FKQ 1984-04-20

CHEMLYTE

Applicant Diachem Laboratories

K number K834395

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FKQ 1984-04-13

HEMODIAL CONCENTRATE

Applicant Moana Productions, Inc.

K number K834587

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FKQ 1984-04-02

HOSPAL MODEL H1210

Applicant Hospal Medical Corp.

K number K840814

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FKQ 1984-04-02

BIOSPAL 1200S

Applicant Hospal Medical Corp.

K number K840813

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FKQ 1984-04-02

BIOSPAL 2400S

Applicant Hospal Medical Corp.

K number K840812

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FKQ 1984-04-02

BIOSPAL 3000S

Applicant Hospal Medical Corp.

K number K840811

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FKQ 1983-09-12

GAMMA STERIL. CAPILLARY FLOW DIALY-G15

Applicant Travenol Laboratories, S.A.

K number K832663

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FKQ 1983-08-08

GAMMA STERILIZED CAPILLARY FLOW DIALYZ

Applicant Travenol Laboratories, S.A.

K number K831940

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FKQ 1983-06-08

BICARBONATE/VARIABLE SODIUM KIT-DM-367

Applicant Extracorporeal Medical Specialities, Inc.

K number K830908

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FKQ 1982-11-22

HEMAFLO BLOOD TUBING SETS

Applicant Cobe Laboratories, Inc.

K number K823092

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FKQ 1982-10-04

DISSCAP 080

Applicant Hospal Medical Corp.

K number K822851

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FKQ 1982-09-30

CIDEX*DIALYZER DISINFECTING SOLUTION

Applicant Surgikos, Inc.

K number K822535

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FKQ 1982-08-30

HPF 100,200,300 CAPILLARY FLOW DIALYZ

Applicant Erika, Inc.

K number K822485

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FKQ 1982-07-02

MODEL 100 BICARBONATE CONDUCTIVITY

Applicant Western Laboratories Corp.

K number K821834

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FKQ 1982-04-16

DISSCAP 110

Applicant Hospal Medical Corp.

K number K820966

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FKQ 1982-04-16

DISSCAP 140

Applicant Hospal Medical Corp.

K number K820965

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FKQ 1982-04-16

GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL

Applicant Gambro, Inc.

K number K820769

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FKQ 1981-09-29

DIALYSATE CONCENTRATE

Applicant Central Biological Co.

K number K812330

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FKQ 1981-06-23

MODEL DM-333 DIALYSIS CONTROL STATION

Applicant Extracorporeal Medical Specialities, Inc.

K number K811444

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FKQ 1981-05-01

PORTADIAL CARRY-ON KIDNEY MACHINE

Applicant Alan P. Kendal, Ph.D.

K number K802297

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FKQ 1981-04-29

HEMOPHRON

Applicant Renal Devices, Inc.

K number K810612

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FKQ 1981-03-20

ALTERNATE STERILIZ. FOR CELLULOSE ACET

Applicant Cordis Corp.

K number K810315

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FKQ 1980-05-20

MOD. DM-356 IPS INTERFACE MODULE

Applicant Extracorporeal Medical Specialities, Inc.

K number K800771

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FKQ 1980-03-12

DMS 3000

Applicant Renal Care Corp.

K number K792252

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FKQ 1978-09-07

PATIENT AID, MODEL DM-351

Applicant Extracorporeal Medical Specialities, Inc.

K number K781176

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FKQ 1978-03-31

DIALYZING FLUIDE DELIVERY SYSTEM

Applicant Travenol Laboratories, S.A.

K number K780081

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FKQ 1978-01-03

HEMODIALYSIS APPARATUS

Applicant Heald Manufacturing, Inc.

K number K772161

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FKQ 1977-09-15

PRESSURE MODULE 5M1247

Applicant Travenol Laboratories, S.A.

K number K771375

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FKQ 1976-12-06

BEDSIDE CONSOLES (11-3-910 & 11-3-930)

Applicant Seattle Artificial Kidney Supply Co.

K number K760965

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