Tubing, Fluid Delivery

FDA product code FPK · 64 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5440
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-03-10 – 2013-08-02

FPK 2013-08-02

MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

Applicant Medrad, Inc. / Bayer Medical Care, Inc.

K number K131517

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FPK 2007-02-09

DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES

Applicant Coeur, Inc.

K number K063114

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FPK 2006-12-11

LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526

Applicant Hospira, Inc.

K number K063239

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FPK 2005-11-29

MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1

Applicant Medtronic Minimed

K number K052431

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FPK 2004-07-16

EMPOWER TRANSFER SET, (CAT. NO. 7725)

Applicant E-Z-Em, Inc.

K number K041178

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FPK 2003-07-11

MEDRAD SWABBABLE VALVE TRANSFER SET

Applicant Medrad, Inc.

K number K031808

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FPK 2002-09-05

MEDRAD TRANSFER SET

Applicant Medrad, Inc.

K number K022431

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FPK 1997-02-26

POLYFIN EXTENSION SET, MODELS 126 AND 128

Applicant Medtronic Minimed

K number K965208

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FPK 1995-11-06

SILCLEAR TUBING (MODIFICATION)

Applicant Degania Silicone , Ltd.

K number K953864

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FPK 1995-11-03

SYSMEX SF-3000

Applicant Sysmex Corp.

K number K950508

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FPK 1995-07-26

EXTENSION SET/I.V. SET

Applicant Coast Medical, Inc.

K number K952243

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FPK 1995-07-14

60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP

Applicant Distronic Sterile Products, Inc.

K number K952663

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FPK 1995-05-26

RECONSTITUTION ACCESSOREIS

Applicant Organon, Inc.

K number K950861

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FPK 1995-05-23

EXTENTION SET

Applicant Mediziv Medical Products 1987 , Ltd.

K number K933524

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FPK 1995-03-24

IVID

Applicant Scott/Ross Designs, Inc.

K number K950200

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FPK 1995-03-16

SILCLEAR TUBING

Applicant Degania Silicone , Ltd.

K number K943992

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FPK 1995-03-09

VARIOUS TUBING

Applicant Prn Services, Inc.

K number K943206

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FPK 1995-02-08

INTRAVASCULAR ADMINISTRATION SET

Applicant Distronic Sterile Products, Inc.

K number K945184

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FPK 1994-10-03

LIFESHIELD EXTENSION SET

Applicant Abbott Mfg., Inc.

K number K941214

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FPK 1994-01-28

EVANS MEDICAL EXTENSION SETS

Applicant Evans Medical, Inc.

K number K935642

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FPK 1993-02-05

NON-INVASIVE TUBING

Applicant Specialty Medical Sales, Inc.

K number K921450

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FPK 1992-11-04

OPHTHALMIC FLUID DISTRIBUTION SETS

Applicant Visitec Co.

K number K923972

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FPK 1992-05-14

LO-PROFILE EXTENSION SET

Applicant Douglas Medical Products Corp.

K number K915560

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FPK 1991-12-13

LIFESHIELD EXTENSION SET

Applicant Abbott Laboratories

K number K912103

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FPK 1991-04-01

CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS

Applicant Tri-State Hospital Supply Corp.

K number K910906

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FPK 1989-05-16

INTRAVASCULAR ADMINISTRATION SET MODEL 60040

Applicant 3M Company

K number K891009

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FPK 1989-05-11

INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050

Applicant 3M Company

K number K891005

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FPK 1989-01-30

MERIT HI-FLEX(TM)

Applicant Merit Medical Systems, Inc.

K number K883718

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FPK 1988-11-14

HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET

Applicant Sechrist Industries, Inc.

K number K884156

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FPK 1988-11-07

CMS IV EXTENSION SETS

Applicant Churchill Medical Systems, Inc.

K number K884370

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FPK 1988-02-16

IV EXTENSION SET

Applicant Marquette Medical, Inc.

K number K875186

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FPK 1988-01-20

VAN DELLEN BACTERIA FILTER

Applicant Van Dellen, Ltd.

K number K873465

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FPK 1987-11-23

INFUSION MANIFOLD

Applicant Advanced Surgical Products, Inc.

K number K873852

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FPK 1987-11-17

PLASTIC TUBING CONNECTOR

Applicant American Medical Technology, Inc.

K number K874360

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FPK 1987-06-15

EXTENSION TUBE PUMP SET

Applicant Churchill Corp.

K number K871085

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FPK 1987-04-30

SWIVEL CONNECTORS #014452/#014453/#014459-120

Applicant Clinical Connections, Inc.

K number K871540

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FPK 1987-04-06

LP EXTENSION SETS

Applicant North Coast Medi-Tek

K number K870416

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FPK 1987-03-17

T-CONNECTORS 014500/014501/014502/014503-120

Applicant Clinical Connections, Inc.

K number K870912

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FPK 1987-02-10

VARIOUS LUER AND TUBING FITTINGS

Applicant Clinical Connections, Inc.

K number K870326

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FPK 1986-12-18

EXTENSION SETS

Applicant Salt Creek Medical Technologies

K number K864692

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FPK 1986-12-16

LOW VOLUME EXTENSION SET

Applicant Panamedix, Inc.

K number K864395

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FPK 1986-06-02

CHURCHILL EXTENSION TUBE

Applicant Churchill Corp.

K number K861626

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FPK 1985-12-10

CHURCHILL-H EXTENSION TUBE

Applicant Churchill Corp.

K number K854629

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FPK 1983-12-13

SPINAL NEEDLES & ACCESSORY

Applicant Elfa Trading Co.

K number K834164

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FPK 1983-11-29

IV EXTENSION SET

Applicant Dna Medical, Inc.

K number K833659

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FPK 1983-11-21

C-FLEX MEDICAL GRADE TUBING

Applicant Concept, Inc.

K number K833076

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FPK 1983-09-12

RED COLOR-TINTED TUBING

Applicant Custom Medical, Inc.

K number K832758

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FPK 1982-03-18

ANESTHESIA EXTENSION TUBES

Applicant David Simmonds Co., Inc.

K number K820527

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FPK 1981-11-06

FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)

Applicant Venusa , Ltd.

K number K812981

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FPK 1981-07-13

SEA MEDICAL PRODUCTS LO-VOL

Applicant Sea Medical Products, Inc.

K number K811847

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FPK 1981-02-05

SAFEED EXTENSION TUBES

Applicant Terumo Medical Corp.

K number K810005

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FPK 1980-06-17

CLEAR PLASTIC CONNECTING TUBES

Applicant Harvard Laboratories

K number K800879

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FPK 1980-06-17

ANESTHESIA EXTENSION TUBES

Applicant Harvard Laboratories

K number K800877

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FPK 1980-05-14

EXTENSION SET QUEST CODE #3000

Applicant Quest Medical, Inc.

K number K800825

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FPK 1978-11-22

MEDICAL GRADE SILICONE ELASTOMER TUBING

Applicant Mcghan Medical Corp.

K number K781087

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FPK 1978-05-16

CENTRAL CATHETER KIT

Applicant Argon Medical Corp.

K number K780673

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FPK 1978-03-22

NASAL GASTRIC TUBE RETAINER

Applicant Mor-Mac, Inc.

K number K780396

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FPK 1977-11-14

TIME WATCH

Applicant Akzona, Inc.

K number K772119

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FPK 1977-09-12

BLOOD COLLECTION SET TYPE H

Applicant Berman, Pcp & Consultants, Inc.

K number K771269

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FPK 1977-08-22

MONITORING LINES & FLUID ADMIN.

Applicant Norton Performance Plastics Corp.

K number K771387

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FPK 1977-06-29

POUCH, TYVEK-POLYMYLON

Applicant Medical Disposables Intl., Inc.

K number K770945

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FPK 1977-06-20

CONNECTORS

Applicant Abco Dealers, Inc.

K number K770596

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FPK 1977-03-30

LUER-LOCK EXTENSION SET

Applicant American Viggo

K number K770174

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FPK 1977-03-10

TUBE HOLDING DEVICE

Applicant Pharmaseal Div., Baxter Healthcare Corp.

K number K770108

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