Accessories, Blood Circuit, Hemodialysis

FDA product code KOC · 179 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: 1976-08-30 – 2025-05-15

KOC 1983-03-29

WAK WEARABLE ARTIFICIAL KIDNEY

Applicant Wak-Utah

K number K830291

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KOC 1983-03-29

AMPCO KIDNEY DIALYSIS TRAY

Applicant Associated Medical Products Co.

K number K823839

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KOC 1983-03-17

ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES

Applicant Advocacy International, Ltd.

K number K830231

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KOC 1983-03-17

ASAHI HOLLOW FIBER KIDNEYS NR SERIES

Applicant Advocacy International, Ltd.

K number K830183

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KOC 1983-02-16

KF-101-13 DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K822339

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KOC 1983-02-16

KF-101-10 DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K822338

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KOC 1983-02-16

KF-101-07 DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K822337

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KOC 1983-02-07

SINGLE ACCESS DEVICE (SSAD)

Applicant Samaritan Hospital

K number K823715

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KOC 1983-01-26

MEDISYSTEMS FISTULA NEEDLES

Applicant Medisystems Corp.

K number K823068

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KOC 1983-01-21

KF-E SERIES HOLLOW FIBER DIALYZER

Applicant Medisystems Corp.

K number K823069

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KOC 1983-01-14

A.V. FISTULA CANNULATION SETS

Applicant Travenol Laboratories, S.A.

K number K830021

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KOC 1983-01-14

EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR

Applicant Advocacy International, Ltd.

K number K823733

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KOC 1983-01-12

CAPILLARY FLOW DIALYZERS

Applicant Travenol Laboratories, S.A.

K number K823826

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KOC 1983-01-12

LUNDIA 10-5-L PARRALLE FLOW DIALYZER

Applicant Gambro, Inc.

K number K823791

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KOC 1983-01-07

GAMMA STERILIZED CAPILLARY FLOW DIALYZ

Applicant Travenol Laboratories, S.A.

K number K823778

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KOC 1983-01-05

HOSPAL BLOOD LINES

Applicant Hospal Medical Corp.

K number K823707

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KOC 1982-12-16

RENAFLO II

Applicant Renal Systems, Inc.

K number K823546

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KOC 1982-12-07

NEPHROSS, ANDANTE H.F.

Applicant Organon Teknika Corp.

K number K823375

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KOC 1982-11-03

EXTRACORPOREAL SINGLE NEEDLE MODULE

Applicant Extracorporeal Medical Specialities, Inc.

K number K822340

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KOC 1982-10-18

NEGATIVE PRESSURE ARTERIAL BLOOD LINE

Applicant Erika, Inc.

K number K822796

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KOC 1982-09-24

TRIEX-IH DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K822738

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KOC 1982-09-02

NEPHROSOL

Applicant Dialysis Systems, Inc.

K number K822244

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KOC 1982-08-27

TS-000 ARTERIOVENOUS BLOOD TUBING SET

Applicant Extracorporeal Medical Specialities, Inc.

K number K822283

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KOC 1982-08-16

ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN

Applicant Erika, Inc.

K number K822226

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KOC 1982-08-16

ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE

Applicant Erika, Inc.

K number K822225

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KOC 1982-08-16

LUNDIA 10-5 N PARALLEL FLOW DIALYZER

Applicant Gambro, Inc.

K number K822049

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KOC 1982-05-28

GF-180-M & GF-180-H HEMODIALYZERS

Applicant Gambro, Inc.

K number K821367

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KOC 1982-05-27

DISPOSABLE BLOOD LINE CONNECTORS

Applicant Bentley Laboratories, Inc.

K number K821495

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KOC 1981-09-29

CLIRANS TE12 HOLLOW FIBER DIALYZER

Applicant Terumo Medical Corp.

K number K812498

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KOC 1981-08-04

ISOLATER THP

Applicant Tri-Med, Inc.

K number K811981

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KOC 1981-07-31

HEMASITE ACCESS MONITOR (TENT.) #RS-8200

Applicant Renal Systems, Inc.

K number K811977

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KOC 1981-06-23

MODEL RS-8100

Applicant Rinal Systems, Inc.

K number K811457

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KOC 1981-03-13

SCANLAN SUTURE BOOTS

Applicant Scanlan Intl., Inc.

K number K810480

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KOC 1981-03-04

ACCUFLO 100

Applicant Renal Care Corp.

K number K810074

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KOC 1980-07-08

BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET

Applicant Cordis Corp.

K number K801356

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KOC 1980-07-08

BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR

Applicant Cordis Corp.

K number K801355

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KOC 1980-07-08

BIONICS ARTERIAL/VENOUS FISTULA NEEDLE

Applicant Cordis Corp.

K number K801354

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KOC 1980-01-16

MODEL 7620 LINE CLAMP

Applicant B-D Drake Willock

K number K792277

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KOC 1979-11-13

COAXIAL DUAL FLOW CATHETER

Applicant Terumo America, Inc.

K number K791411

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KOC 1979-06-27

TG 2, TRI-GARD PRESSURE MONITOR

Applicant Sorensen Research

K number K790841

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KOC 1979-05-02

HEMODIALYSIS BLOOD CIRCUIT

Applicant Travenol Laboratories, S.A.

K number K790591

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KOC 1979-04-20

ARTERIOVENOUS SETS

Applicant Extracorporeal Medical Specialities, Inc.

K number K790381

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KOC 1978-09-26

DLC 500, DOUBLE LUMEN CATHETER

Applicant Hemodialysis, Division of The

K number K781050

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KOC 1977-08-26

TUBE OCCLUDING FORCEPS

Applicant Quinton, Inc.

K number K771424

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KOC 1977-04-28

GAMBRO VENOUS BLOOD LINE

Applicant Gambro, Inc.

K number K770691

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KOC 1977-04-15

CATHETER, SINGLE PUNCTURE Y

Applicant Mdl Medical Device Laboratories, Inc.

K number K770482

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KOC 1977-03-30

CATHETER, KIDNEY DIALYSIS, HEMO-CATH II

Applicant Medical Disposables Intl., Inc.

K number K770552

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KOC 1977-03-30

TRANSDUCER PROTECTOR, RT-901, RT-902

Applicant Renal Systems, Inc.

K number K770524

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KOC 1977-03-16

PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2

Applicant Travenol Laboratories, S.A.

K number K770475

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KOC 1977-03-08

NEEDLE, FISTULA, ERIKA

Applicant Erika, Inc.

K number K770382

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KOC 1977-03-07

STOPCOCK, ONE WAY

Applicant Cobe Laboratories, Inc.

K number K770383

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KOC 1977-02-07

BARIOR

Applicant Tri-Med, Inc.

K number K770213

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KOC 1977-01-14

DNC 162 VINCA-FLO

Applicant Sorensen Research

K number K770048

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KOC 1977-01-14

DNC 142 VINCA-FLO

Applicant Sorensen Research

K number K770046

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KOC 1977-01-14

DNC 152 VINCA-FLO

Applicant Sorensen Research

K number K770045

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KOC 1977-01-14

DNC 141 VINCA-FLO

Applicant Sorensen Research

K number K770044

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KOC 1977-01-14

DNC 161 VINCA-FLO

Applicant Sorensen Research

K number K770043

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KOC 1977-01-06

MONITOR LINE W/FILTER & NEEDLE

Applicant Dravon Medical, Inc.

K number K760994

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KOC 1976-12-30

BI-FLOW NEEDLE

Applicant Dws, Inc.

K number K761051

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KOC 1976-12-06

SINGLE NEEDLE HEMODIALYSIS (BFC-142)

Applicant Sorensen Research

K number K761082

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KOC 1976-12-06

SINGLE NEEDLE HEMODIALYSIS (BFC-161)

Applicant Sorensen Research

K number K761081

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KOC 1976-12-06

HEMO-CATH I, KIDNEY DIALYSIS CATHETER

Applicant Medical Disposables Intl., Inc.

K number K761078

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KOC 1976-12-06

SINGLE NEEDLE HEMODIALYSIS

Applicant Sorensen Research

K number K761038

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KOC 1976-11-19

WINGED FISTULA NEEDLE

Applicant Gambro, Inc.

K number K760935

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KOC 1976-10-21

FISTULA NEEDLE (#11-265)

Applicant Cobe Laboratories, Inc.

K number K760665

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KOC 1976-10-15

FILTER SET, PMF 1024

Applicant Sorensen Research

K number K760640

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KOC 1976-10-15

FILTER SET, PMF 2028

Applicant Sorensen Research

K number K760639

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KOC 1976-10-15

FILTER, PMF 1000

Applicant Sorensen Research

K number K760638

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KOC 1976-10-15

FILTER SET, PMF 1448

Applicant Sorensen Research

K number K760637

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KOC 1976-10-15

FILTER SET PMF 1028

Applicant Sorensen Research

K number K760633

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KOC 1976-10-15

FILTER SET PMF 2024

Applicant Sorensen Research

K number K760632

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KOC 1976-10-15

FILTER SET 1288

Applicant Sorensen Research

K number K760631

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KOC 1976-10-15

FILTER SET PMF 200

Applicant Sorensen Research

K number K760630

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KOC 1976-10-15

FILTER SET PMF 100

Applicant Sorensen Research

K number K760629

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KOC 1976-10-15

FILTER SET PMF 2448

Applicant Sorensen Research

K number K760628

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KOC 1976-10-15

FILTER SET PMF 2168

Applicant Sorensen Research

K number K760627

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KOC 1976-10-15

FILTER SET PMF 2288

Applicant Sorensen Research

K number K760626

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KOC 1976-10-15

FILTER SET PMF 1168

Applicant Sorensen Research

K number K760625

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KOC 1976-08-30

BLOOD TUBING SETS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K760042

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