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DQE — Catheter, Oximeter, Fiber-Optic Class II

FDA Device Classification

Classification Details

Product Code
DQE
Device Class
Class II
Regulation Number
870.1230
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172423edwards lifesciencePediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry CeFebruary 20, 2018
K160645edwards lifesciencesPreSep Oligon Oximetry CatheterJune 16, 2016
K140129icu medicalPICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETJuly 2, 2014
K110167edwards lifesciencesPRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)February 18, 2011
K091268hospiraHOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSSeptember 18, 2009
K062999hospiraOPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINNovember 3, 2006
K061585hospiraOPTICATH CENTRAL VENOUS OXIMETRY CATHETEROctober 5, 2006
K061450hospiraHOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CAugust 4, 2006
K061159hospiraOPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARINJune 26, 2006
K060093edwards lifesciencesPRESEP OLIGON OXIMETRY CATHETERSApril 28, 2006
K053609edwards lifesciencesPRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTFebruary 28, 2006
K926450baxter healthcareEDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHFebruary 22, 1993
K915073marquette electronicsMARQUETTE SV O2 MODULEDecember 29, 1992
K905458baxter healthcareSWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERFebruary 7, 1991
K901736baxter healthcareOXIMETRY PROBE CATHETERSSeptember 11, 1990
K864745criticare systemsPOET OXIMETERJune 2, 1987
K820674oximetrixOPTICATHMarch 25, 1982
K781134oximetrixCATHETER, THERMAL DILUTION FIBEROPTICAugust 17, 1978
K760234oximetrixOXIMETER, IN VIVO CATHETERAugust 23, 1976