Catheter, Peritoneal, Long-Term Indwelling

FDA product code FJS · 48 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5630
Review panel: GU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-11-28 – 2022-01-14

FJS 2022-01-14

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

Applicant Covidien, LLC

K number K213602

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FJS 2018-07-27

Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

Applicant Covidien, LLC

K number K180485

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FJS 2013-04-19

FALLER STYLET

Applicant Medionics International, Inc.

K number K130441

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FJS 2012-09-05

PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)

Applicant Medical Components, Inc.

K number K121383

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FJS 2012-05-21

FALLER TROCAR

Applicant Medigroup, Inc.

K number K120130

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FJS 2012-03-13

VETA PERITONEAL DIALYSIS CATHETER

Applicant Pfm Medical, Inc.

K number K113354

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FJS 2007-08-31

FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560

Applicant Medigroup, Inc.

K number K071167

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FJS 2007-07-03

FLEX-NECK ARC CATHETER

Applicant Medigroup, Inc.

K number K070730

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FJS 2006-07-18

EMBEDDING TOOL, MODEL TE-1000

Applicant Medigroup, Inc.

K number K060897

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FJS 2006-03-29

PD CATH

Applicant Med-Conduit, Inc.

K number K053123

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FJS 2003-09-17

FLEX-NECK PD CATHETER, INFANT

Applicant Medigroup, Inc.

K number K031351

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FJS 2002-02-04

MEDIGROUP CATHETER EXTENDER/REPAIR KIT

Applicant Janin Group, Inc.

K number K012502

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FJS 2001-12-06

MEDIGROUP KEY TUBE

Applicant Janin Group, Inc.

K number K013017

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FJS 2000-04-28

PERITONEAL DIALYSIS CATHETERS AND ADAPTERS

Applicant Medionics International, Inc.

K number K993149

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FJS 1999-06-25

ASH ADVANTAGE PERITONEAL CATHETER

Applicant Janin Group, Inc.

K number K991042

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FJS 1997-09-05

FLEX-NECK PD CATHETER

Applicant Janin Group, Inc.

K number K970159

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FJS 1997-07-18

ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II

Applicant Sil-Med Corp.

K number K961392

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FJS 1995-12-15

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER

Applicant Accurate Surgical Instruments Co.

K number K950042

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FJS 1994-09-23

CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS

Applicant Tabex Industries, Inc.

K number K934610

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FJS 1994-06-23

CATH BELT PD CATHETER AND TRANSFER SET HOLDER

Applicant Tabex Industries, Inc.

K number K930175

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FJS 1994-02-02

MEDCOMP PERITONEAL DIALYSIS CATHETERS

Applicant Medical Components, Inc.

K number K915490

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FJS 1992-05-04

INSERTION

Applicant Accurate Surgical Instruments Co.

K number K920515

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FJS 1991-09-19

TROCAR (FALLER STYLET)

Applicant Accurate Surgical Instruments Co.

K number K910786

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FJS 1991-08-22

TITANIUM CATHETER EXTENDER

Applicant Accurate Surgical Instruments Co.

K number K910785

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FJS 1990-10-22

LIFECOIL CATHETER

Applicant Lifemed of California

K number K903502

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FJS 1990-07-27

PERITONEAL CATHETERS

Applicant Akcess Medical Products, Inc.

K number K902101

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FJS 1989-03-27

PERITONEAL CATHETERS WITH AN ADDED FUNCTION

Applicant Quinton, Inc.

K number K890288

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FJS 1989-01-31

TRUDELL BENT CATHETER

Applicant Sil-Med Corp.

K number K885167

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FJS 1987-07-16

VAS-CATH PERITONEAL DIALYSIS CATHETER

Applicant Vas-Cath of Canada , Ltd.

K number K871817

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FJS 1987-02-04

CHEMO-CATH INTRAPERITONEAL CATHETER

Applicant Hdc Corp.

K number K863819

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FJS 1986-09-09

PERITONEAL DIALYSIS CATHETERS

Applicant Thermedics, Inc.

K number K863128

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FJS 1986-06-19

SWAN-NECK PERITONEAL DIALYSIS CATHETERS

Applicant Accurate Surgical Instruments Co.

K number K862046

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FJS 1985-12-19

LONG TERM PERITONEAL CATHETER

Applicant Thermadics, Inc.

K number K854614

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FJS 1985-07-26

STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN

Applicant Accurate Surgical Instruments Co.

K number K850214

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FJS 1982-05-21

GORE-TEX PERITONEAL CATHETERR

Applicant W. L. Gore & Associates, Inc.

K number K820909

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FJS 1981-12-31

CATHETER REGULAR

Applicant Accurate Surgical Instruments Co.

K number K813488

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FJS 1981-10-19

CUFF MATERIAL ON PEDIATRIC SIZE CATH.

Applicant Quinton, Inc.

K number K812718

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FJS 1981-10-02

TENCKHOFF PERITONEAL CATHETERS

Applicant Quinton, Inc.

K number K812607

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FJS 1981-03-13

MIROMED PERITONEAL DIALYSIS CATHETER

Applicant American Medical Products, Inc.

K number K810236

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FJS 1980-10-23

TENCKHOFF CATHETER

Applicant Sil-Med Corp.

K number K801818

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FJS 1980-10-03

BETA-CAP II

Applicant Quinton, Inc.

K number K801679

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FJS 1979-02-27

CATHETER, BETA-CAP-PERITONEAL

Applicant Dravon Medical, Inc.

K number K782058

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FJS 1979-02-27

CATHETER, RADIOPAQUE TENCKHOFF

Applicant Dravon Medical, Inc.

K number K782057

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FJS 1978-05-16

BETA CAP SYSTEM

Applicant Quinton, Inc.

K number K780449

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FJS 1978-04-27

SHADOW-CATHS

Applicant Quinton, Inc.

K number K780643

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FJS 1977-11-28

PERITONEAL DIALYSIS CATHETER

Applicant Fluoro-Mold Co.

K number K771555

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FJS 1977-11-28

CATHETER FINGER GRIP

Applicant Quinton, Inc.

K number K771483

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FJS 1977-11-28

BETA-CAP

Applicant Quinton, Inc.

K number K771420

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