Atlas FDA

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

FDA 510(k) clearance K043256 · decided 2004-12-06

Clearance details

K-number
K043256
Device name
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2004-11-24
Decision date
2004-12-06
Days to decision
12 days
Clearance type
Special
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Lake Forest, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia saf recall (Z-1517-2015)Hospira Inc.2015-04-23
Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, I recall (Z-2346-2012)Hospira, Inc.2012-09-10
Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09 recall (Z-0601-06)Hospira Inc2006-03-09

PMA approvals by this applicant

RecordFirmDate
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
DEXTRAN HM 32 (P880028/S002)Hospira, Inc.1990-11-15
DEXTRAN HM 32 (P880028/S001)Hospira, Inc.1989-12-29
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30