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Stopcock, I.V. Set

FDA product code FMG · 88 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: 1976-12-02 – 2025-04-29

FMG 2025-04-29

Qitexio® 4-Way Stopcock (QIT014)

Applicant Medex

K number K242255

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FMG 2023-07-21

Three Way Stop Cock

Applicant M/S Romsons International

K number K223499

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FMG 2023-03-10

lntravascular Administration Sets with Stopcock and Manifold

Applicant Baxter Healthcare Corporation

K number K223175

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FMG 2022-09-15

SafePort(TM) Manifold (or Stopcock)

Applicant Elcam Medical Acal

K number K211204

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FMG 2022-05-16

Clicky Cross

Applicant Yomura Technologies, Inc.

K number K210516

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FMG 2019-10-22

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

Applicant Monumedical, LLC

K number K190539

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FMG 2019-04-23

Elcam Stopcocks and Manifolds

Applicant Elcam Medical Acal

K number K190489

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FMG 2018-03-14

Dynarex Three-Way Stopcock

Applicant Dynarex Corporation

K number K172266

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FMG 2013-05-23

DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD

Applicant Elcam Medical Acal

K number K123084

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FMG 2013-03-01

LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO

Applicant Baxter Healthcare Corp

K number K130245

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FMG 2009-06-17

DUAL SYRINGE HOLDER

Applicant Surgin Surgical Instrumentation, Inc.

K number K082110

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FMG 2009-02-25

ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES

Applicant Icu Medical, Inc.

K number K082836

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FMG 2008-10-02

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)

Applicant Elcam Medical Acal

K number K082106

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FMG 2008-02-13

CLAVE STOPCOCK

Applicant Icu Medical, Inc.

K number K080077

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FMG 2007-12-14

SMARTSITE STOPCOCK

Applicant Cardinal Health, Alaris Products

K number K071400

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FMG 2007-04-10

JMS PLANECTA STOPCOCK

Applicant Jms North America Corp.

K number K070143

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FMG 2006-05-11

BACSTOP

Applicant Elcam Medical Acal

K number K053405

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FMG 2006-05-10

ROBERTSITE STOPCOCK

Applicant Halkey-Roberts Corp.

K number K061143

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FMG 2006-04-13

CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK

Applicant Elcam Medical Acal

K number K060231

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FMG 2005-09-09

TRU-SWAB STOCOCK

Applicant Medegen Medical Manufacturing Services

K number K052330

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FMG 2004-09-21

NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L

Applicant Nipro Medical Corp.

K number K041779

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FMG 2003-09-12

INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)

Applicant Elcam Medical Acal

K number K032393

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FMG 2002-10-18

ELCAM STOPCOCKS AND MANIFOLDS

Applicant Medical Device Consultants, Inc.

K number K022895

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FMG 2001-09-11

CHURCHILL MEDICAL SYSTEMS STOPCOCK

Applicant Churchill Medical Systems, Inc.

K number K012157

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FMG 2001-03-18

4 PORT, 4 WAY STOPCOCK

Applicant George Loo, MD

K number K010217

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FMG 1998-07-31

MANIFOLD WITH EXTENSION SET

Applicant Interpore Cross Intl.

K number K982368

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FMG 1998-01-13

CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS

Applicant Ohmeda Medical

K number K974083

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FMG 1997-04-02

PRIMARY IV SET

Applicant Icu Medical, Inc.

K number K964435

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FMG 1997-02-21

TRI-FLOW THREE WAY STOPCOCK

Applicant North, Inc.

K number K961982

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FMG 1996-08-28

STOPCOCK MANIFOLD GANGS

Applicant Baxter Healthcare Corp

K number K962581

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FMG 1996-04-22

STOPCOCK & LUER LOCK PLUG

Applicant Medex, Inc.

K number K954970

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FMG 1996-02-21

MED-NET STOPCOCKS

Applicant Mednet, Inc.

K number K955782

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FMG 1996-01-23

MINIBORE STOPCOCK SET

Applicant Distronic Sterile Products, Inc.

K number K954984

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FMG 1995-10-07

ICU STOPCOK WITH EXTENSION TUBING

Applicant Icu Medical, Inc.

K number K953573

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FMG 1994-04-04

STOPCOCK INTRAVENOUS THERAPY

Applicant Puritas Health Care, Inc.

K number K940070

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FMG 1994-02-22

MULTI-PORT MANIFOLD

Applicant Baxter Healthcare Corp

K number K932512

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FMG 1991-12-31

STOPCOCK

Applicant Graham Medical Products

K number K913560

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FMG 1991-06-03

TRUMPET VALVE

Applicant B. Braun of America, Inc.

K number K911415

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FMG 1990-12-05

ADVANCE DISPOSABLE STOPCOCK

Applicant Advance Medical Designs, Inc.

K number K902724

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FMG 1989-09-19

TERUFUSION THREE WAY STOPCOCK

Applicant Terumo Medical Corp.

K number K891234

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FMG 1989-01-09

CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS

Applicant Ohmeda Medical

K number K884463

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FMG 1988-11-08

RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS

Applicant Clinical Connections, Inc.

K number K884435

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FMG 1988-10-04

TU STOPCOCK

Applicant Tulan Corp. C/O Richard Hamer Assoc.

K number K881805

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FMG 1987-08-04

STERICAP ASSEMBLY AND REPLACEMENT TRAY

Applicant Stericap Systems

K number K872067

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FMG 1987-08-04

STERICAP STOPCOCK

Applicant Stericap Systems

K number K872066

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FMG 1987-04-01

VIGGO EXACTA PRESSURE MONITORING SYSTEM

Applicant Ohmeda Medical

K number K870261

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FMG 1987-04-01

VIGGO EXACTA PRESSURE MONITORING KIT

Applicant Ohmeda Medical

K number K864900

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FMG 1987-03-13

#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK

Applicant Clinical Connections, Inc.

K number K870324

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FMG 1987-01-20

CHURCHILL 3-WAY STOPCOCK

Applicant Churchill Corp.

K number K864440

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FMG 1986-09-25

EXEL THREE-WAY STOPCOCK

Applicant Exel Intl.

K number K862492

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FMG 1986-07-28

STOPCOCK

Applicant Ram Development

K number K862691

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FMG 1986-04-07

SAMPLE MANIFOLD HOLDER

Applicant R. Bell

K number K860889

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FMG 1985-11-08

CHURCHILL 3-WAY STOPCOCK SET

Applicant Churchill Corp.

K number K854348

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FMG 1985-08-16

CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD

Applicant Icu Medical, Inc.

K number K853275

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FMG 1985-05-23

STOPCOCKS

Applicant Transamerica Delaval, Inc.

K number K851986

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FMG 1985-04-11

VIGGO CONNECTA 3-WAY INFUSION STOPCOCK

Applicant Viggo Products

K number K850280

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FMG 1984-09-05

DISPOSABLE STOPCOCKS

Applicant Procedure Products, Inc.

K number K842173

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FMG 1984-03-19

STOPCOCKS & EXTENSION TUBES

Applicant American Pharmaseal Div. Ahsc

K number K840394

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FMG 1983-02-07

PEDIATRIC EXTEN. SET FOR SECOND-DRUG

Applicant Travenol Laboratories, S.A.

K number K830198

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FMG 1982-12-30

TERUFUSION THREE-WAY STOPCOCK

Applicant Terumo Medical Corp.

K number K823469

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FMG 1982-12-30

BENZING RETROGRADE ADMIN. SET

Applicant Beech Medical, Inc.

K number K823373

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FMG 1982-11-08

EXACTA & CONNECTA STOPCOCKS W/EXTENSION

Applicant Pioneer Viggo, Inc.

K number K823120

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FMG 1982-02-01

FLOW MED 311

Applicant D.R.O. Medical, Inc.

K number K820165

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FMG 1981-11-06

ARTERIOGRAM TRAY

Applicant American Pharmaseal Div. Ahsc

K number K812927

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FMG 1981-02-26

CENTURION STOPCOCK 3 WAY

Applicant Tri-State Hospital Supply Corp.

K number K810375

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FMG 1980-09-26

STOPCOCK 2-WAY, 3-WAY & 4-WAY

Applicant Stanco Medical, Inc.

K number K802258

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FMG 1980-05-30

STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE

Applicant Custom Medical Devices Intl., Inc.

K number K800864

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FMG 1980-05-30

TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS

Applicant Custom Medical Devices Intl., Inc.

K number K800863

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FMG 1980-05-30

1,3 & 4 WAY STERILE DIS. PLASTIC PKG.

Applicant Custom Medical Devices Intl., Inc.

K number K800862

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FMG 1980-02-26

THREE-WAY STOPCOCK EXTENSION SET 20-SL

Applicant Abbott Laboratories

K number K800284

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FMG 1980-01-16

STERILE EXTENSION TUBES INDIV. PKG.

Applicant Tronomed, Inc.

K number K792128

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FMG 1980-01-16

PLAS. STCK. W/EXTENSION TUBE/STERILE

Applicant Tronomed, Inc.

K number K792127

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FMG 1980-01-16

3&4 WAY PLASTIC STERILE STPCKS. PKG.

Applicant Tronomed, Inc.

K number K792126

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FMG 1980-01-16

3&4 WAY PLASTIC STOPCOCKS, NONSTERILE

Applicant Tronomed, Inc.

K number K792125

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FMG 1980-01-16

TANDEM ASSEMBLED 3&4 WAY STOPCOCKS

Applicant Tronomed, Inc.

K number K792124

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FMG 1979-02-22

3-WAY STOPCOCK

Applicant Medex, Inc.

K number K782168

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FMG 1979-02-21

DELTA FLOW

Applicant Medex, Inc.

K number K782167

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FMG 1979-02-01

MANIFOLD, DISPOSABLE 3 VALVE

Applicant Cordis Corp.

K number K790010

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FMG 1978-06-06

SUPPLEMENTAL TYGON PAC-MONITORING LINES

Applicant Norton Performance Plastics Corp.

K number K780662

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FMG 1978-04-19

STOPCOCK

Applicant Abco Dealers, Inc.

K number K780596

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FMG 1977-12-08

PLASTIC STOPCOCK W/ EXTENSION TUBE

Applicant Medon Corp.

K number K771911

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FMG 1977-06-17

TYGON PAC-MONITORING LINES & FLUID ADMIN

Applicant Norton Performance Plastics Corp.

K number K770916

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FMG 1977-06-08

TYGON PAC-STOPCOCKS

Applicant Norton Performance Plastics Corp.

K number K770708

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FMG 1977-06-03

TYGON PAC-MONITORING LINES & FLUID ADMIN

Applicant Norton Performance Plastics Corp.

K number K770707

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FMG 1976-12-02

4-WAY STOPCOCK W/7CM TUBING,

Applicant American Viggo

K number K760679

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FMG 1976-12-02

4-WAY STOPCOCK W/100 CM TUBING, LUER-LK

Applicant American Viggo

K number K760678

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FMG 1976-12-02

4-WAY STOPCOCK W/10 CM EXTEN. TUBING

Applicant American Viggo

K number K760667

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FMG 1976-12-02

4-WAY STOPCOCK W/LUER-LOCK FITTING

Applicant American Viggo

K number K760666

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