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 1991-09-24

FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N-

Applicant Biocor, Inc.

K number K912861

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FPA 1991-09-23

3 PORT ADAPTER

Applicant Baxter Healthcare Corp

K number K913627

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FPA 1991-09-13

SAFETY INJECTION PORT, MODIFICATION

Applicant Riverside Technology, Inc.

K number K913311

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FPA 1991-09-11

VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE

Applicant Baxter Healthcare Corp

K number K912141

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FPA 1991-09-06

MEDIZIV INFUSION SET

Applicant Medicia Medical Products

K number K911128

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FPA 1991-09-06

WINGED ADMININ. SET W/NON-CORING NEEDLE

Applicant Dmd Products

K number K910159

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FPA 1991-08-28

INTRAVASCULAR ADMINISTRATION SETS

Applicant Pacific Device, Inc.

K number K912860

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FPA 1991-08-02

3RD HAND HELPER

Applicant Aaron Medical Industries

K number K911815

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FPA 1991-07-26

INSUL-LINE

Applicant Trademark Corp.

K number K911443

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FPA 1991-06-24

INTERLINK(TM) BLUNT CANNULA, MODIFICATION

Applicant Baxter Healthcare Corp

K number K911868

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FPA 1991-06-24

INTERVASCULAR ADMINSTRATION SET

Applicant Mcgaw, Inc.

K number K911753

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FPA 1991-06-18

LUER LOCK INJECTION CAP

Applicant Dmd Products

K number K911931

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FPA 1991-06-14

B-D SAFETY-LOK(TM) I.V. NEEDLES

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K911136

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FPA 1991-06-04

4' LOW VOLUME IV EXTENSION SET

Applicant Marquette Medical, Inc.

K number K905219

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FPA 1991-06-04

4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP

Applicant Marquette Medical, Inc.

K number K905218

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FPA 1991-05-31

IV EXTENSION SETS WITH .22 MICRON FILTER

Applicant Marquette Medical, Inc.

K number K905374

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FPA 1991-05-14

SPARK KIT(R), MODIFICATION

Applicant Lyphomed, Inc.

K number K910142

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FPA 1991-04-29

PIGGY LOCK NEEDLE HOUSING

Applicant Icu Medical, Inc.

K number K910546

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FPA 1991-03-21

AUTO SASH (TM)

Applicant Block Medical, Inc.

K number K910695

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FPA 1991-01-11

VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS

Applicant Florida Infusion Services, Inc.

K number K904886

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FPA 1990-12-14

AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET

Applicant 3M Avi, Inc.

K number K902858

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FPA 1990-11-21

EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)

Applicant Exel Intl.

K number K904685

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FPA 1990-11-13

STERILE I.V. START KIT

Applicant Orion Life Systems, Inc.

K number K902810

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FPA 1990-10-19

STATLOCK IV CONNECTOR AND ANCHOR SET

Applicant Venetec, Inc.

K number K902109

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FPA 1990-10-04

LOW VOLUME TRIFURCATED IV EXTENSION SET

Applicant Marquette Medical, Inc.

K number K901089

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FPA 1990-10-04

LOW VOLUME BIFURCATED IV EXTENSION SET

Applicant Marquette Medical, Inc.

K number K901088

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FPA 1990-10-04

V SET

Applicant Go Medical Industries Pty. , Ltd.

K number K900336

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FPA 1990-10-03

PRO-LOK (TM) EXTENSION SETS

Applicant Vlv Associates, Inc.

K number K904217

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FPA 1990-10-03

PROTECTED NEEDLE WITH OR WITHOUT IV SET

Applicant Kendall Mcgaw Laboratories, Inc.

K number K903809

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FPA 1990-10-01

SPIVE NEEDLE SYSTEM, MODIFICATION

Applicant Pascall Medical Corp.

K number K904013

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FPA 1990-09-21

E-Z FLO + SET

Applicant Prn Services, Inc.

K number K902330

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FPA 1990-09-14

SAFETY INJECTION PORT

Applicant Du-Call Miller Plastics, Inc.

K number K903541

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FPA 1990-09-12

IV SET

Applicant Jfv, Inc.

K number K901949

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FPA 1990-09-12

KAWASUMI SMALL VEIN INFUSION SET

Applicant Kawasumi Laboratories Co., Ltd.

K number K896896

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FPA 1990-09-12

KAWASUMI I.V. ADMINISTRATION SET

Applicant Kawasumi Laboratories Co., Ltd.

K number K896895

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FPA 1990-09-12

KAWASUMI BLOOD ADMINISTRATION SET

Applicant Kawasumi Laboratories Co., Ltd.

K number K896894

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FPA 1990-09-12

KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE

Applicant Kawasumi Laboratories Co., Ltd.

K number K896893

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FPA 1990-09-12

KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET

Applicant Kawasumi Laboratories Co., Ltd.

K number K896892

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FPA 1990-08-17

WINGED INFUSION SET

Applicant Therex Corp.

K number K902166

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FPA 1990-07-19

EXEL HUBER INFUSION SET

Applicant Exel Intl.

K number K895770

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FPA 1990-07-02

I.V. ADMINISTRATION SET CONNECTING DEVICE

Applicant Dmd, Div. of Casta Pacific Co.

K number K901151

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FPA 1990-06-26

MODIFIED STICK-GARD SAFETY NEEDLE

Applicant Ziehm International, Inc.

K number K902196

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FPA 1990-06-22

SHIELDED PIGGYBACK IV NEEDLE

Applicant Pascall Saringia Medical Corp.

K number K900353

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FPA 1990-06-18

SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET

Applicant Ryan Medical, Inc.

K number K901729

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FPA 1990-06-08

PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY

Applicant Vlv Associates, Inc.

K number K901081

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FPA 1990-06-08

VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR

Applicant Vlv Associates, Inc.

K number K901046

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FPA 1990-05-18

IN-LINE VIAL CONNECTION SITE

Applicant Baxter Healthcare Corp

K number K900909

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FPA 1990-05-07

TS-1800 MEDICATION TRANSFER SPIKE

Applicant The Medi-Dose Group

K number K900651

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FPA 1990-05-01

ADVANCE ADMINISTRATION SETS (VARYING LENGTH)

Applicant Advance Medical Designs, Inc.

K number K900188

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FPA 1990-05-01

ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)

Applicant Advance Medical Designs, Inc.

K number K900187

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FPA 1990-03-09

I.V. FREEDOM CLIP

Applicant Infection Control Products, Inc.

K number K900644

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FPA 1990-02-28

IV TRIFURCATED EXTENSION SET

Applicant Marquette Medical, Inc.

K number K900427

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FPA 1990-02-28

IV BIFURCATED EXTENSION SET

Applicant Marquette Medical, Inc.

K number K900426

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FPA 1990-02-16

PORT INFUSION SET (PIS) INFUSION SET (IS)

Applicant Prn Services, Inc.

K number K897065

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FPA 1990-02-01

EXTENSION SET

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

K number K896561

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FPA 1990-01-18

GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK

Applicant Pharmacia Deltec, Inc.

K number K896346

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FPA 1990-01-11

AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.

Applicant 3M Company

K number K896161

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FPA 1989-12-27

IV DISPESNSING SPIKE

Applicant The Medi-Dose Group

K number K895291

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FPA 1989-12-27

CHEMO-SPIKE RECONSTITUTION DEVICE

Applicant The Medi-Dose Group

K number K895290

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FPA 1989-12-06

VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY

Applicant Baxter Healthcare Corp

K number K893646

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FPA 1989-12-01

INJECTION PORT II --- FOR INTERMITTENT INJECTION

Applicant The Medi-Dose Group

K number K896291

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FPA 1989-12-01

BLUNT NEEDLE PORT/I.V. PORT

Applicant Applied Medical Technologies

K number K895480

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FPA 1989-10-25

REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE

Applicant Pharmacia Deltec, Inc.

K number K895046

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FPA 1989-10-10

SHAMROCK SAFETY WINGED INFUSION SET

Applicant Ryan Medical, Inc.

K number K895481

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FPA 1989-10-06

INTRAVENOUS EXTENSION SET

Applicant Medical Product Specialists

K number K895367

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FPA 1989-09-27

SECONDARY IV SET WITH PROTECTED NEEDLE

Applicant Kendall Mcgaw Laboratories, Inc.

K number K895109

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FPA 1989-09-19

MEDI-TRACE ACCU-NATE DEVICE

Applicant Graphic Controls Corp.

K number K891193

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FPA 1989-09-18

VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000

Applicant Baxter Healthcare Corp

K number K893716

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FPA 1989-09-13

MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT

Applicant New York Blood Center, Inc.

K number K894787

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FPA 1989-09-12

IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM

Applicant Imed Corp.

K number K894842

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FPA 1989-08-25

MODIFIED MATERIAL USED IN INFUSION T

Applicant Quinton, Inc.

K number K893909

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FPA 1989-07-27

KIT, INTRAVENOUS EXTENSION TUBING

Applicant Island Medical

K number K893120

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FPA 1989-07-25

INJECTION PORT FOR---INTERMITTENT INJECTION

Applicant The Medi-Dose Group

K number K892429

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FPA 1989-07-24

KENDALL CURITY EXTENSION TUBES

Applicant The Kendal Co.

K number K892440

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FPA 1989-07-24

KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES

Applicant The Kendal Co.

K number K892438

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FPA 1989-06-23

SAMUELS - MICRO -SCLER CATHETER

Applicant Polyval, Inc.

K number K891164

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FPA 1989-06-23

TERUMO SURFLO(R) INJECTION PLUG

Applicant Terumo Medical Corp.

K number K891146

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FPA 1989-06-23

SURFLO(R) WINGED INFUSION SET

Applicant Terumo Medical Corp.

K number K891063

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FPA 1989-06-08

EXTENSION SET W/FLOW REGULATOR

Applicant Baxter Healthcare Corp

K number K890489

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FPA 1989-05-30

VASCULAR ACCESS PORT CONTINUOUS INFUSION SET

Applicant Infucare Products, Inc.

K number K891226

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FPA 1989-05-18

INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION)

Applicant Multi-Med, Inc.

K number K891176

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FPA 1989-05-05

LOW ADSORPTION ADMINISTRATION SET

Applicant 3M Company

K number K885031

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FPA 1989-05-01

SCALP VEIN SET

Applicant Ashley Health Care, Inc.

K number K890679

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FPA 1989-04-26

EXTENSION SETS WITH AND WITHOUT FILTERS

Applicant Medical Support Systems

K number K890176

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FPA 1989-04-21

INTRAVASCULAR ADMINISTRATION SET

Applicant Multi-Med, Inc.

K number K891072

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FPA 1989-04-04

SAFE MULTIPORT INJECTOR

Applicant L & W Ent.

K number K884511

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FPA 1989-03-31

INTRAVASCULAR ADMINISTRATION SET

Applicant Multi-Med, Inc.

K number K890340

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FPA 1989-03-22

LILY I.V. SET

Applicant Modec Co., Inc.

K number K884657

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FPA 1989-02-28

MONOPLACE HYPERBARIC EXTENSION SET (L 11055)

Applicant Abbott Laboratories

K number K884141

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FPA 1989-02-24

CRIS ADAPTER

Applicant Y

K number K883986

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FPA 1989-01-31

WINGED INFUSION SET

Applicant E-Z-Em, Inc.

K number K885264

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FPA 1989-01-31

MODIFIED 7 INCH CONTINUOUS INFUSION SETS

Applicant Quinton, Inc.

K number K884102

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FPA 1989-01-24

STANDARD ADMINISTRATION SETS

Applicant 3M Company

K number K885030

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FPA 1988-12-19

INTRAVASCULAR ADMINISTRATION SET

Applicant Device Labs, Inc.

K number K883764

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FPA 1988-11-14

HIGH RISK NEEDLE CONNECTOR ASSEMBLY

Applicant Venture Molded Products, Inc.

K number K884264

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FPA 1988-10-31

PRN PLUS + INFUSION SET

Applicant Prn Services, Inc.

K number K884053

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FPA 1988-10-21

VALLEYLAB I.V. ADMINISTRATION SETS

Applicant Valleylab, Inc.

K number K883318

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FPA 1988-09-29

LECTROSPIRAL

Applicant Vygon Corp.

K number K883612

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FPA 1988-09-23

SAFESITE INJECTION SITE AND BLUNT CANNULA

Applicant Baxter Healthcare Corp

K number K883638

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FPA 1988-08-30

HARMAC EXTENSION INFUSION SET

Applicant Harmac Medical Specialties, Inc.

K number K882347

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