Set, Administration, Intravascular

FDA product code FPA · 1138 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: 1976-07-16 – 2026-09-11

FPA 2008-08-18

TRITON MEIDCAL TMED IV-SET

Applicant Triton Medical, LLC

K number K073444

View details →

FPA 2008-08-14

UNASSIGNED

Applicant Medcomp

K number K080544

View details →

FPA 2008-08-07

ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG

Applicant B.Braun Medical, Inc.

K number K073396

View details →

FPA 2008-08-05

EZ REGULAR

Applicant Meinntech Co., Ltd.

K number K080303

View details →

FPA 2008-08-04

V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE

Applicant Baxter Healthcare Corp

K number K081289

View details →

FPA 2008-07-18

CADD MEDICATION CASSETTE RESERVOIR

Applicant Smiths Medical MD, Inc.

K number K081156

View details →

FPA 2008-07-01

MOBILE I.V. SYSTEMS 10,20,60

Applicant Northwind Technologies, Corp.

K number K080695

View details →

FPA 2008-05-13

NOVOLET

Applicant U.S. Safety Syringes Co., Inc.

K number K080665

View details →

FPA 2008-05-13

IV ADMINISTRATION SET

Applicant U.S. Safety Syringes Co., Inc.

K number K080660

View details →

FPA 2008-01-25

SAFESTEP MAX POWER-INJECTABLE INFUSION SET

Applicant Specialized Health Products International, Inc.

K number K073050

View details →

FPA 2007-12-13

SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET

Applicant AngioDynamics, Inc.

K number K072375

View details →

FPA 2007-11-06

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

Applicant Terumo Europe N.V.

K number K072894

View details →

FPA 2007-11-06

CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED

Applicant Baxter Healthcare Corp

K number K072576

View details →

FPA 2007-10-05

POLYPERF / POLYPERF SAFE

Applicant Laboratoires Perouse

K number K063631

View details →

FPA 2007-10-04

PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

Applicant Promepla

K number K071421

View details →

FPA 2007-09-25

MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR

Applicant Medegen Medical Manufacturing System

K number K072542

View details →

FPA 2007-08-31

HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE

Applicant Health Line International Corporation (Hlic)

K number K070630

View details →

FPA 2007-08-30

MODIFICATION TO EZ HUBER SAFETY INFUSION SET

Applicant Pfm Medical, Inc.

K number K071846

View details →

FPA 2007-05-25

SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)

Applicant Terumo Europe N.V.

K number K070547

View details →

FPA 2007-05-24

IMM HYPODERMIC NEEDLE SET

Applicant Innovative Medical Manufacturing Co.

K number K070801

View details →

FPA 2007-05-07

SURFLO WINGED INFUSION SET

Applicant Terumo Europe N.V.

K number K070362

View details →

FPA 2007-04-04

PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS

Applicant Unomedical A/S

K number K070430

View details →

FPA 2007-03-20

SPIROS

Applicant Icu Medical, Inc.

K number K070532

View details →

FPA 2007-03-20

LMT-KATH-S; LMT-KATH-I

Applicant Licher Medizintechnologie GmbH

K number K062308

View details →

FPA 2007-03-09

REPEATER PUMP II TUBE SETS

Applicant Baxa Corp.

K number K062909

View details →

FPA 2007-02-21

ACCU-CHEK ULTRAFLEX INFUSION SET

Applicant Disetronic Medical Systems AG

K number K070189

View details →

FPA 2006-07-31

INTUITION INFUSION SETS

Applicant Unomedical A/S

K number K061374

View details →

FPA 2006-07-26

SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS

Applicant Cardinal Health, Alaris Products

K number K061285

View details →

FPA 2006-07-10

EZ-CONNECT

Applicant Vidacare Corporation

K number K061771

View details →

FPA 2006-06-30

SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216

Applicant Gvs Spa

K number K061115

View details →

FPA 2006-06-08

DERMATECH IV HOLDER

Applicant Dermatech Medical, Inc.

K number K060488

View details →

FPA 2006-06-06

K-SHIELD PORT ACCESS INFUSION SET

Applicant Kawasumi Laboratories, Inc.

K number K060580

View details →

FPA 2006-05-31

HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS

Applicant Health Line International Corporation

K number K060352

View details →

FPA 2006-03-31

ONE STICK Y EXTENSION SET AND VOLUMETER

Applicant One Stick, LLC

K number K060672

View details →

FPA 2006-03-31

TIANJIN MEDIS DISPOSABLE INFUSION SET

Applicant Tianjin Medis International Trade Co., Ltd.

K number K060082

View details →

FPA 2006-03-29

INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326

Applicant Baxter Healthcare Corp

K number K060074

View details →

FPA 2006-01-12

ALARIS SAFETY MALE LUER

Applicant Cardinal Health, Alaris Products

K number K053049

View details →

FPA 2006-01-10

TEGO, MODEL D1000

Applicant Icu Medical, Inc.

K number K053106

View details →

FPA 2005-12-08

NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5

Applicant Nexus Medical, LLC

K number K053129

View details →

FPA 2005-12-08

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS

Applicant Terumo Europe N.V.

K number K052887

View details →

FPA 2005-11-29

MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2

Applicant Medtronic Minimed

K number K052432

View details →

FPA 2005-11-16

CONTRAST MEDIA TRANSFER SETS

Applicant B.Braun Medical, Inc.

K number K052252

View details →

FPA 2005-11-02

LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS

Applicant Hospira, Inc.

K number K052722

View details →

FPA 2005-10-12

SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET

Applicant Renascence Medical, Inc.

K number K052658

View details →

FPA 2005-10-04

SUREFLOW SAFETY INFUSION DEVICE

Applicant Intrasafe Medical, LLC

K number K051943

View details →

FPA 2005-09-01

COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS

Applicant Unomedical A/S

K number K051264

View details →

FPA 2005-08-23

VITALCARE I.V. ADMINISTRATION SET

Applicant Vitalcare Group, Inc.

K number K050906

View details →

FPA 2005-08-03

CML 1000

Applicant Icu Medical, Inc.

K number K051437

View details →

FPA 2005-08-01

MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR

Applicant Medegen Medical Manufacturing System

K number K051939

View details →

FPA 2005-07-13

ANGIODYNAMICS TUMESCENT INFUSION DEVICE

Applicant AngioDynamics, Inc.

K number K051142

View details →

FPA 2005-07-12

HUBER CLEAR SAFETY INFUSION SET

Applicant Now Medical Distribution, Inc.

K number K051009

View details →

FPA 2005-06-22

INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

Applicant Medegen Medical Manufacturing Services

K number K051499

View details →

FPA 2005-05-12

MINILOC SAFETY INFUSION SET

Applicant Specialized Health Products, Intl.

K number K050600

View details →

FPA 2005-04-15

MICROFLO-SAFE SCALP VEIN SET

Applicant Dks Loversan Industria Biomedica Spa

K number K043328

View details →

FPA 2005-04-15

PENTADEFLUE IV SOLUTION ADMINISTRATION SETS

Applicant Pentaferte S.P.A

K number K041495

View details →

FPA 2005-04-07

BD POSIFLOW POSITIVE DISPLACEMENT VALVE

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K050207

View details →

FPA 2005-03-08

DRAGON HEART I.V. SET

Applicant Dragon Heart Medical Devices Co., Ltd.

K number K043235

View details →

FPA 2005-01-27

F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK

Applicant Cedic S.R.L.

K number K042129

View details →

FPA 2004-12-21

LUTH-ALL SUB-Q NEEDLE SET

Applicant Luth-All Medical Products, LLC

K number K042666

View details →

FPA 2004-11-26

SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE

Applicant Baxter Healthcare Corp

K number K042936

View details →

FPA 2004-11-26

NEXUS INTRAVENOUS TUBING SETS (NIVTS)

Applicant Nexus Medical, LLC

K number K041861

View details →

FPA 2004-10-29

IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING

Applicant B.Braun Medical, Inc.

K number K041490

View details →

FPA 2004-10-21

IV ADMINISTRATION SET B400 SP

Applicant Codan US Corp.

K number K042693

View details →

FPA 2004-10-07

CLEO 90 INFUSION SET

Applicant Smiths Medical MD, Inc.

K number K042172

View details →

FPA 2004-10-04

PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606

Applicant Clinico

K number K041919

View details →

FPA 2004-09-17

EZ HUBER SAFETY INFUSION SET

Applicant Pfm Medical, Inc.

K number K040533

View details →

FPA 2004-09-08

MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET

Applicant Specialty Health Products, Inc.

K number K042234

View details →

FPA 2004-09-03

ALL SAFE HUBER SAFETY INFUSION SETS

Applicant Nexus Medical, LLC

K number K041844

View details →

FPA 2004-09-01

Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432

Applicant Icu Medical, Inc.

K number K042182

View details →

FPA 2004-08-24

NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4

Applicant Nexus Medical, LLC

K number K041845

View details →

FPA 2004-08-11

TEGO NEEDLE FREE ACCESS ACCESS DEVICE

Applicant Icu Medical, Inc.

K number K040710

View details →

FPA 2004-07-28

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118

Applicant Icu Medical, Inc.

K number K041410

View details →

FPA 2004-07-16

SPLIT SEPTUM INJECTION SITES

Applicant Fresenius Medical Care North America

K number K041042

View details →

FPA 2004-06-30

CONTACT DETACH

Applicant Unomedical A/S

K number K041545

View details →

FPA 2004-06-04

MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR

Applicant Medegen Medical Manufacturing Services, Inc.

K number K041179

View details →

FPA 2004-06-03

LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES

Applicant Lily Medical Supplies Co., Ltd.

K number K032767

View details →

FPA 2004-05-19

CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET

Applicant Smiths Medical MD, Inc.

K number K040636

View details →

FPA 2004-04-12

TALON INFUSION SET, MODEL IP XXXX

Applicant Icu Medical, Inc.

K number K033290

View details →

FPA 2004-04-07

MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900

Applicant Quest Medical, Inc.

K number K040385

View details →

FPA 2004-04-01

CLICK-ON

Applicant Unomedical A/S

K number K040633

View details →

FPA 2004-03-26

LOW PROFILE LUTHER SAFETY HUBER

Applicant Luther Needlesafe Products, Inc.

K number K040527

View details →

FPA 2004-03-18

IVY DEVICES INC. IV/MEDICAL LINE STABILIZER

Applicant Ivy Devices, Inc.

K number K033208

View details →

FPA 2004-03-09

ULTRAFLEX INFUSION SET

Applicant Disetronic Medical Systems AG

K number K033892

View details →

FPA 2004-03-04

IV ADMINISTRATION AND CONNECT SETS

Applicant Codan US Corp.

K number K033301

View details →

FPA 2004-01-22

HUBERPRO SAFETY HUBER INFUSION SET

Applicant Command Medical Products

K number K033515

View details →

FPA 2003-12-04

LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE

Applicant Abbott Laboratories

K number K033576

View details →

FPA 2003-12-04

CLC2000 CATHETER PATENCY DEVICE

Applicant Icu Medical, Inc.

K number K021692

View details →

FPA 2003-11-18

BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER

Applicant Becton, Dickinson & CO

K number K033350

View details →

FPA 2003-11-13

MPS ACACIA SAFEGUARD HUBER DEVICE

Applicant Mps Acacia

K number K032934

View details →

FPA 2003-10-28

MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313

Applicant Medtronic Minimed

K number K032485

View details →

FPA 2003-10-28

MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310

Applicant Medtronic Minimed

K number K032484

View details →

FPA 2003-10-16

ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109

Applicant Applied Diabetes Research, Incorporated

K number K033099

View details →

FPA 2003-10-09

UNOMEDICAL MONICA INFUSION SET

Applicant Unomedical A/S

K number K032854

View details →

FPA 2003-09-12

SAFETY-MULTIFLY

Applicant Sarstedt, Inc.

K number K032150

View details →

FPA 2003-09-08

MARQUETTE HUBER TRAP SAFETY INFUSION SET

Applicant Marquette Medical, Inc.

K number K021471

View details →

FPA 2003-08-29

V SET

Applicant Hennig Enterprises Europe Srl

K number K020424

View details →

FPA 2003-08-29

V SET

Applicant P.T. Greenleaf

K number K020419

View details →

FPA 2003-08-19

MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S

Applicant Medtronic Minimed

K number K031917

View details →

FPA 2003-08-11

ULTRASITE VALVE

Applicant B.Braun Medical, Inc.

K number K031923

View details →

FPA 2003-07-25

EXCEL PRIMARY SOLUTION SET

Applicant Exelint Intl. Co.

K number K031500

View details →