Product code DQE— Cardiovascular

FDA has cleared 19 devices under product code DQE between 1976 and 2018, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20181 clearance
• 20161 clearance
• 20141 clearance
• 20111 clearance
• 20091 clearance
• 20066 clearances
• 19931 clearance
• 19921 clearance
• 19911 clearance
• 19901 clearance
• 19871 clearance
• 19821 clearance
• 19781 clearance
• 19761 clearance

• Hospira, Inc.5 clearances
• Edwards Lifesciences, LLC4 clearances
• Oximetrix, Inc.3 clearances
• Baxter Healthcare Corp3 clearances
• Marquette Electronics, Inc.1 clearance
• Icu Medical, Inc.1 clearance
• Edwards Lifescience, LLC1 clearance
• Criticare Systems, Inc.1 clearance

• K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC·2018-02-20
• K160645 — PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC·2016-06-16
• K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETERIcu Medical, Inc.·2014-07-02
• K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLC·2011-02-18
• K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.·2009-09-18
• K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINHospira, Inc.·2006-11-03
• K061585 — OPTICATH CENTRAL VENOUS OXIMETRY CATHETERHospira, Inc.·2006-10-05
• K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERSHospira, Inc.·2006-08-04
• K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARINHospira, Inc.·2006-06-26
• K060093 — PRESEP OLIGON OXIMETRY CATHETERSEdwards Lifesciences, LLC·2006-04-28
• K053609 — PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOREdwards Lifesciences, LLC·2006-02-28
• K926450 — EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHBaxter Healthcare Corp·1993-02-22
• K915073 — MARQUETTE SV O2 MODULEMarquette Electronics, Inc.·1992-12-29
• K905458 — SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERBaxter Healthcare Corp·1991-02-07
• K901736 — OXIMETRY PROBE CATHETERSBaxter Healthcare Corp·1990-09-11
• K864745 — POET OXIMETERCriticare Systems, Inc.·1987-06-02
• K820674 — OPTICATHOximetrix, Inc.·1982-03-25
• K781134 — CATHETER, THERMAL DILUTION FIBEROPTICOximetrix, Inc.·1978-08-17
• K760234 — OXIMETER, IN VIVO CATHETEROximetrix, Inc.·1976-08-23