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Pump, Infusion, Pca

FDA product code MEA · 31 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: 1991-06-11 – 2017-08-29

MEA 2017-08-29

ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

Applicant Summit Medical Products, Inc.

K number K162165

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MEA 2017-08-24

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

Applicant Smiths Medical Ads, Inc.

K number K170982

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MEA 2016-04-08

LifeCare PCA Infusion System

Applicant Hospira, Inc.

K number K143612

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MEA 2013-12-09

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

Applicant Smiths Medical Asd, Inc.

K number K130394

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MEA 2009-11-04

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM

Applicant B.Braun Medical, Inc.

K number K092313

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MEA 2008-03-07

CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR

Applicant Smiths Medical MD, Inc.

K number K072144

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MEA 2005-07-15

MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)

Applicant Baxter Healthcare Corp

K number K051253

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MEA 2004-12-10

MEDLEY PCA MODULE, MODEL 8120

Applicant Alaris Medical Systems, Inc.

K number K043299

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MEA 2004-12-06

HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03

Applicant Hospira, Inc.

K number K043256

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MEA 2004-10-18

LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

Applicant Hospira, Inc.

K number K042800

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MEA 2003-12-16

HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP

Applicant Harvard Clinical Technology

K number K033054

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MEA 2003-09-09

MEDLEY PCA MODULE, MODEL 8120

Applicant Alaris Medical Systems, Inc.

K number K032233

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MEA 2003-08-19

SYNDEO PCA SYRINGE PUMP, MODEL 2L3113

Applicant Baxter Healthcare Corp

K number K031566

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MEA 2003-05-30

STRYKER PAINPUMP2

Applicant Stryker Instruments

K number K030661

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MEA 2003-04-29

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

Applicant Hennig Enterprises Europe Srl

K number K020421

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MEA 2003-04-29

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

Applicant P.T. Greenleaf

K number K020418

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MEA 2002-08-01

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

Applicant Abbott Laboratories

K number K022203

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MEA 2002-05-08

MICROJET CRONO PCA

Applicant Cane S.R.L.

K number K013822

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MEA 2000-09-11

INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K

Applicant Baxter Healthcare Corp

K number K002739

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MEA 2000-08-23

PALM PUMP

Applicant Sorenson Medical, Inc.

K number K002434

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MEA 1999-04-22

AVIA PAIN MEDICATION DELIVERY SYSTEM

Applicant Amtec Medical

K number K990312

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MEA 1998-11-02

CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300

Applicant Sims Deltec, Inc.

K number K982839

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MEA 1995-02-21

MODEL 6100 AMBULATORY INFUSION SYSTEM

Applicant Pharmacia Deltec, Inc.

K number K943310

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MEA 1994-03-17

VERIFUSE AMBULATORY PUMP

Applicant Block Medical, Inc.

K number K934551

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MEA 1993-01-15

PRIME PCA AND PCA/CONTINUOUS SYSTEMS

Applicant Prime Medical Products, Inc.

K number K920637

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MEA 1992-08-24

PATIENT CONTROLLED SYRINGE PUMP TYPE 3300

Applicant Graseby Medical , Ltd.

K number K915270

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MEA 1992-08-03

BARD PCA II PUMP WITH PROGRAM CARTRIDGES

Applicant C.R. Bard, Inc.

K number K921994

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MEA 1992-06-03

IVAC PC ANIFUSER

Applicant Y

K number K915063

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MEA 1991-12-18

BARD PCA II PUMP WITH PROGRAM CARTRIDGES

Applicant C.R. Bard, Inc.

K number K914502

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MEA 1991-11-07

BAXA PCA INFUSOR

Applicant Baxa Corp., Sub. of Cook Group, Inc.

K number K910257

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MEA 1991-06-11

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP

Applicant Pharmacia Deltec, Inc.

K number K911791

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