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Catheter, Irrigation

FDA product code GBX · 76 cleared devices

Class 1 General, Plastic Surgery

Regulation: 21 CFR 878.4200
Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-03-30 – 2008-12-17

GBX 2008-12-17

GRAFTGUARD PRESSURE CONTROLLING SYRINGE

Applicant Maquet Cardiovascular, LLC

K number K082725

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GBX 2005-10-21

DEUTSCH ANTI-BLOCKAGE WOUND DRAIN

Applicant The Catheter Exchange, Inc.

K number K052286

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GBX 2005-03-31

GRAFTSAVER

Applicant Vescare, Inc.

K number K043515

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GBX 2002-01-10

MISONIX IRRIGATION SYSTEM MOEDL BC20P

Applicant Misonix, Inc.

K number K013417

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GBX 2000-05-19

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

Applicant Dmc Medical, Ltd.

K number K000704

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GBX 1998-02-03

LYSONIX IRRIGATION SYSTEM

Applicant Lysonix, Inc.

K number K974233

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GBX 1997-12-04

JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN

Applicant Allegiance Healthcare Corp.

K number K973703

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GBX 1997-10-01

ULTRACELL SUCTION SPONGE

Applicant Ultracell Medical Technologies, Inc.

K number K972635

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GBX 1997-03-10

FLAT CLOSED WOUND DRAIN WITH TROCAR

Applicant Axiom Medical, Inc.

K number K965146

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GBX 1996-06-26

SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR

Applicant Sil-Med Corp.

K number K961295

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GBX 1996-05-31

CLOSED FLUID COLLECTION SYSTEM

Applicant B.Braun Medical, Inc.

K number K961147

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GBX 1996-05-22

JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING

Applicant Baxter Healthcare Corp

K number K960955

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GBX 1996-03-13

HYDROLOGY 5000

Applicant Northgate Technologies, Inc.

K number K955339

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GBX 1996-02-13

NEO-PNEUMOCATH

Applicant Intra Special Catheters GmbH

K number K955474

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GBX 1996-02-07

OPTI-DRAIN MULTI-USE DRAINAGE CATHETER

Applicant Navarre Biomedical , Ltd.

K number K955505

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GBX 1995-12-26

THE REEL THING (MODIFICATION)

Applicant Biomedical Devices, Inc.

K number K955439

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GBX 1995-05-24

SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN

Applicant Sil-Med Corp.

K number K926496

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GBX 1995-05-15

NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER

Applicant Navarre Biomedical , Ltd.

K number K951907

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GBX 1995-04-24

NAVARRE UNIVERSAL DRAINAGE CATHETER

Applicant Navarre Biomedical , Ltd.

K number K951475

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GBX 1995-03-14

INSYTE SIDEHOLDED DRAINAGE CATHETER

Applicant Becton Dickinson Vascular Access, Inc.

K number K950439

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GBX 1995-03-14

ANGIOCATH SIDEHOLDER DRAINAGE CATHETER

Applicant Becton Dickinson Vascular Access, Inc.

K number K950437

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GBX 1994-08-09

ACI SILICATH THORACIC CATHETER

Applicant American Catheter

K number K942335

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GBX 1994-07-27

DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER

Applicant Deknatel, Inc.

K number K925243

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GBX 1994-06-07

THE REEL THING

Applicant Bio-Medical Devices, Inc.

K number K940156

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GBX 1994-06-02

ORION SUCTION CATHETER KIT WITH STERILE SALINE

Applicant Regulatory & Marketing Services, Inc.

K number K942274

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GBX 1994-06-02

ORION SUCTION CATHETER KIT WITH STERILE WATER

Applicant Regulatory & Marketing Services, Inc.

K number K942273

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GBX 1994-05-05

OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP

Applicant Puritas Health Care, Inc.

K number K935531

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GBX 1994-04-14

STORZ N5941 SERIES MEDICAL GRADE TUBING

Applicant Storz Instrument Co.

K number K940352

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GBX 1994-03-28

NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS

Applicant Navarre Biomedical , Ltd.

K number K933600

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GBX 1994-02-02

SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE

Applicant Sil-Med Corp.

K number K926495

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GBX 1994-02-02

SIL-SLIP FLAT SUCTION DRAIN

Applicant Sil-Med Corp.

K number K926408

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GBX 1994-01-27

NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET

Applicant Navarre Biomedical , Ltd.

K number K932391

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GBX 1994-01-03

ERCP CATHETER, HYDROPHILIC COATED

Applicant Wilson-Cook Medical, Inc.

K number K932205

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GBX 1993-08-11

URESIL ABSCESS DRIANAGE AND IRRIGATION SET

Applicant Uresil Corp.

K number K925117

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GBX 1993-06-07

FLUID DRAINAGE TRAY

Applicant Symbiosis Corp.

K number K926109

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GBX 1993-05-12

KENDALL UNIVERSAL EXTENSION SET

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K930551

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GBX 1993-04-23

IRRIGATION/SUCTION PROBE

Applicant Surgical Instrument, Inc.

K number K923667

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GBX 1993-04-08

VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE

Applicant Boston Scientific Corp

K number K925176

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GBX 1993-02-26

KENDALL WOUND DRAINAGE SYSTEMS-TROCARS

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K925805

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GBX 1993-01-13

KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K925748

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GBX 1993-01-12

ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET

Applicant Angeion Corp.

K number K925533

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GBX 1993-01-12

TURKEL ABDOMINAL PARACENTESIS SYSTEM

Applicant Symbiosis Corp.

K number K924702

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GBX 1992-09-28

SIL-MED FLAT SUCTION DRAIN

Applicant Sil-Med Corp.

K number K921424

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GBX 1992-08-06

HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE

Applicant Hollister, Inc.

K number K922739

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GBX 1992-07-15

INTRADUCER

Applicant Taut, Inc.

K number K921934

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GBX 1992-04-29

PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT

Applicant Pacer Tool & Plastics, Inc.

K number K921095

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GBX 1992-01-21

THORACIC CATHETER WITH GUIDE

Applicant Intl. Medical Devices , Ltd.

K number K913542

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GBX 1992-01-21

THORACIC CATHTER STYLET

Applicant Intl. Medical Devices , Ltd.

K number K913539

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GBX 1991-04-22

I/A HANDPIECE WITH REPLACEABLE TIPS

Applicant Surgical Technologies, Inc.

K number K910245

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GBX 1991-03-20

JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS

Applicant Baxter Healthcare Corp

K number K905614

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GBX 1991-03-06

DRAINAGE TUBE RESTRAINT/WOUND COVER

Applicant M. Imonti and Associates Inc.,

K number K905766

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GBX 1991-02-11

PVC ROUND WOUND DRAINS

Applicant Axiom Medical, Inc.

K number K905422

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GBX 1990-10-11

DISPOSABLE FLUID COLLECTION BAG

Applicant Axiom Medical, Inc.

K number K904133

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GBX 1989-12-27

MIKRO-AQUAPURATOR

Applicant Mikro-Tek Laboratories

K number K895756

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GBX 1989-12-27

MIKRO-LAVAGE-1

Applicant Mikro-Tek Laboratories

K number K895755

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GBX 1989-12-27

CAVITY DRAINAGE CATHETERIZATION SET, CS-01600

Applicant Arrow Intl., Inc.

K number K895516

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GBX 1989-10-19

IRRI-EVACUATOR

Applicant Mikro-Tek Laboratories

K number K895757

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GBX 1988-09-13

THORACIC CATHETERS

Applicant Westmark, Sterile Packing Systems, Inc. (Sps)

K number K883474

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GBX 1987-03-27

CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET

Applicant American Pharmaseal Div. Ahsc

K number K870704

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GBX 1985-06-27

CONTINUOUS VENTILATOR

Applicant Hamilton Medical, Inc.

K number K844809

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GBX 1985-06-26

HALL IRRIGATION SYSTEM

Applicant Hall Surgical, Division of Zimmer, Inc.

K number K852143

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GBX 1985-06-05

PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,

Applicant Pennine Medical , Ltd.

K number K844876

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GBX 1985-05-21

MICROTEK IRRIGATION SYSTEM

Applicant Microtek Medical, Inc.

K number K844061

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GBX 1985-05-03

VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5

Applicant Vygon Corp.

K number K851475

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GBX 1985-03-18

PERIMETER THORACIC CATHETER

Applicant Perimeter Medical, Inc.

K number K844922

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GBX 1984-11-29

PRUITT IRRIGATION AND OCCLUSION CATHETER

Applicant Bionomy, Inc.

K number K844094

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GBX 1984-10-24

SDC SILICONE SUMP DRAIN

Applicant Science Development Corp.

K number K843617

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GBX 1984-08-02

TIDAL DISTENSION IRRIGATION SET

Applicant Abbott Laboratories

K number K841362

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GBX 1984-04-25

SILICONE SUCTION & IRRIGATION DRAIN

Applicant Superior Plastic Products Corp.

K number K840323

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GBX 1983-05-02

I/A KIT

Applicant Surgeon Surgical Instrumentation, Inc.

K number K830859

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GBX 1982-12-28

ARTHROSCOPIC IRRIGATION SETS-2C4030/31

Applicant Travenol Laboratories, S.A.

K number K823496

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GBX 1982-10-13

SUCTION CATHETER W/STERILE WATER

Applicant Medine Dynacor

K number K822510

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GBX 1978-06-22

IRRIGATION CATHETER

Applicant Shiley, Inc.

K number K780788

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GBX 1977-09-15

CURITY IRRIGATION TRAY

Applicant Kendall Research Center

K number K771079

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GBX 1977-05-06

CATHETER, IRRIGATION

Applicant Mallinckrodt Critical Care

K number K770706

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GBX 1977-03-30

SUMP DRAIN, W/FILTER, ARGYLE EDLICH

Applicant Sherwood Medical Industries

K number K770442

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