FDA.reportPublic FDA data

510(k) K061450

Device
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS
Applicant
Hospira, Inc.
510(k) number
K061450
Product code
DQE
Decision
Substantially Equivalent (SESE)
Decision date
2006-08-04
Date received
2006-05-25
Regulation
870.1230
Classification name
Catheter, Oximeter, Fiber-Optic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THOMAS SAMPOGNA
Address
275 N. Field Dr. Lake Forest IL US 60045 60045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC2018-02-20
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K140129PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETERIcu Medical, Inc.2014-07-02
K110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLC2011-02-18
K091268HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.2009-09-18
K062999OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINHospira, Inc.2006-11-03
K061585OPTICATH CENTRAL VENOUS OXIMETRY CATHETERHospira, Inc.2006-10-05
K061159OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARINHospira, Inc.2006-06-26
K060093PRESEP OLIGON OXIMETRY CATHETERSEdwards Lifesciences, LLC2006-04-28
K053609PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOREdwards Lifesciences, LLC2006-02-28
K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHBaxter Healthcare Corp1993-02-22
K915073MARQUETTE SV O2 MODULEMarquette Electronics, Inc.1992-12-29
K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERBaxter Healthcare Corp1991-02-07
K901736OXIMETRY PROBE CATHETERSBaxter Healthcare Corp1990-09-11
K864745POET OXIMETERCriticare Systems, Inc.1987-06-02