Controller, Infusion, Intravascular, Electronic

FDA product code LDR · 60 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5725
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-09-15 – 2024-10-07

LDR 2024-10-07

DEKA Infusion System, DEKA Administration Set

Applicant Deka Research and Development Corporation

K number K242693

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LDR 2024-03-01

DEKA Infusion System, DEKA Administration Set

Applicant Deka Research and Development

K number K232316

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LDR 2016-10-03

Volumetric Infusion Controller

Applicant DEKA Research & Development

K number K153760

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LDR 1997-10-10

PACER MODEL 100 INFUSION CONTROLLER

Applicant Health Watch, Inc.

K number K963136

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LDR 1997-07-03

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P

Applicant Alexander Mfg. Co.

K number K971865

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LDR 1997-07-03

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500

Applicant Alexander Mfg. Co.

K number K971826

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LDR 1994-03-29

UNIVERSAL CONTROLLER, MODEL 100

Applicant Metamed, Inc.

K number K934543

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LDR 1994-02-24

FLOW CONTROLLING EXTENSION SET

Applicant Block Medical, Inc.

K number K935236

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LDR 1991-04-16

STAT 2 IV PUMPETTE

Applicant The Master Medical Corp.

K number K905498

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LDR 1991-04-16

MASTER FLOW I.V. PUMPETTE

Applicant The Master Medical Corp.

K number K905497

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LDR 1990-02-26

3M IV FLOW REGULATOR

Applicant 3M Company

K number K896907

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LDR 1989-09-28

VARI-SET

Applicant Sonex Medical

K number K894111

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LDR 1989-09-27

IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+

Applicant Y

K number K894487

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LDR 1989-07-28

LIFECARE 75 CONTROLLER

Applicant Abbott Laboratories

K number K893487

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LDR 1988-11-01

IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262

Applicant Y

K number K884307

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LDR 1988-09-23

IVY COMMANDER, MODEL 600

Applicant Ivy Medical, Inc.

K number K882167

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LDR 1988-03-24

STA-SET I.V. FLOW REGULATOR

Applicant Controlled Flow , Ltd.

K number K880006

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LDR 1988-03-03

TECHNICON CHEM 1(TM) SYSTEM

Applicant Technicon Instruments Corp.

K number K874916

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LDR 1988-03-03

IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290

Applicant Y

K number K874481

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LDR 1988-02-25

IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+

Applicant Y

K number K874491

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LDR 1988-01-20

IVY COMMANDER (MODEL 500)

Applicant Ivy Medical, Inc.

K number K870820

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LDR 1987-04-03

IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280

Applicant Y

K number K870317

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LDR 1987-02-05

IVAC FLOW CONTROL ADMINISTRATION SET

Applicant Y

K number K870132

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LDR 1987-02-04

BETAFLO 2000 PIGGYBACK SYSTEM

Applicant Betaflo, Inc.

K number K864789

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LDR 1986-12-16

STA-SET MODEL 250 I.V. FLOW REGULATOR

Applicant Sta-Set Corp.

K number K864229

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LDR 1986-09-03

DEKA JR.

Applicant Deka Research & Development Corp.

K number K863204

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LDR 1986-07-18

BETAFLO 2000

Applicant Betaflo, Inc.

K number K862273

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LDR 1986-02-12

RATEMINDER III INFUSION DEVICE

Applicant American Edwards Laboratories

K number K855000

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LDR 1986-02-12

FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER

Applicant Travenol Laboratories, S.A.

K number K854863

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LDR 1985-04-29

DOSI FLOW

Applicant Leventon, S.A.

K number K851058

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LDR 1984-12-04

ARM-A-FLOW INTRAVENOUS FLOW REGULATOR

Applicant Armour Pharmaceutical Co.

K number K842209

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LDR 1984-10-11

DK*300 VOLUMETRIC INFUSION CONTROLLER

Applicant Deka Research & Development Corp.

K number K843254

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LDR 1984-08-07

IVAC 280 VOLUMETRIC INFUSION CONTROLLER

Applicant Y

K number K842419

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LDR 1984-07-25

IVENT 302VC DUAL CONTROLLER

Applicant Ivent Corp.

K number K842210

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LDR 1984-07-18

ABBOTT LIFECARE 1050 CONTROLLER

Applicant Abbott Laboratories

K number K842080

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LDR 1984-07-18

A.S.A.P.

Applicant Trimedyne, Inc.

K number K841318

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LDR 1984-05-30

INTRAVENOUS INFUSION CONTROLLER

Applicant Cutter Laboratories, Inc.

K number K834106

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LDR 1984-03-30

IVY COMMANDEER

Applicant Ivy Medical, Inc.

K number K840942

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LDR 1984-03-23

TREONIC C30

Applicant Vickers America Medical Corp.

K number K840823

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LDR 1984-03-23

FLO-GARD 4000 VOLUMETRIC INFUSION

Applicant Travenol Laboratories, S.A.

K number K840644

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LDR 1984-02-21

MODEL 2001 INTELLIGENT INFUSOR

Applicant Quest Medical, Inc.

K number K834528

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LDR 1984-01-25

FLO-GARD 8000 COMPUTER CONTROL INFUSI

Applicant Travenol Laboratories, S.A.

K number K834154

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LDR 1983-12-29

ELECTRONIC GRAVITY 300VC

Applicant Ivent Corp.

K number K833953

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LDR 1983-12-22

RATEMINDER II SPECIALTY CARE

Applicant Anatros Corp.

K number K833520

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LDR 1983-12-22

STEDIFLO INFUSION SET

Applicant Dravon Medical, Inc.

K number K832739

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LDR 1983-11-28

PRIMARY PIGGYBACK INFUSION SET W/PERM

Applicant Cosmetic Sciences, Inc.

K number K833682

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LDR 1983-11-17

POCKET AID

Applicant M.C. Johnson Co., Inc.

K number K832702

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LDR 1983-04-08

KOALA C99 I.V. CONTROLLER

Applicant Chesebrough-Pond'S U.S.A. Co.

K number K830780

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LDR 1982-12-22

VOLUMERIC CONTROLLER

Applicant Quest Medical, Inc.

K number K823404

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LDR 1982-11-24

FLO CONTROL

Applicant Dna Medical, Inc.

K number K822891

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LDR 1982-11-22

380 PIGGYBACK CONTROLLER

Applicant Imed Corp.

K number K823026

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LDR 1982-09-14

PERMA-SET INFUSION SET

Applicant Cosmetic Sciences, Inc.

K number K822603

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LDR 1982-07-21

SKIN SCRUB-TRAY

Applicant Associated Medical Products Co.

K number K821579

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LDR 1981-09-16

TRAVENOL INFUSION CONTROLLER 2M8052

Applicant Travenol Laboratories, S.A.

K number K812510

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LDR 1981-08-25

RATEMINDER

Applicant Anatros Corp.

K number K812233

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LDR 1981-08-20

LIFECARE 1000 CONTROLLER

Applicant Abbott Laboratories

K number K812114

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LDR 1981-07-13

MILLIPORE DUAL RATE INTRAVENOUS CASSETTE

Applicant Millipore Corp.

K number K811432

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LDR 1980-08-27

IVAC 260 SERIES VOLUME TRIC INFUSION CON

Applicant Y

K number K801861

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LDR 1977-10-13

ID BRACLETS, ADULT & INFANT

Applicant Divers-A-Med

K number K771158

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LDR 1976-09-15

TUMBLER, GENERAL MEDICAL MEDI-PAK

Applicant Landmark Plastics

K number K760491

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