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510(k) K160645

PreSep Oligon Oximetry Catheter by Edwards Lifesciences, LLC — Product Code DQE

K160645 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "PreSep Oligon Oximetry Catheter". The FDA issued a decision of Substantially Equivalent on June 16, 2016. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2016
Date Received
March 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Oximeter, Fiber-Optic
Device Class
Class II
Regulation Number
870.1230
Review Panel
CV
Submission Type

Other clearances by Edwards Lifesciences, LLC

  • K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial A (June 26, 2026)
  • K251326 — Respiration Rate algorithm (June 11, 2026)
  • K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (June 5, 2026)
  • K254279 — Edwards eSheath+ introducer set (April 17, 2026)
  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253034 — HemoSphere Stream Module (October 21, 2025)
  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K252364 — Edwards eSheath Optima introducer set (August 29, 2025)

Other clearances for product code DQE

  • K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Ce (February 20, 2018)
  • K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHET (July 2, 2014)
  • K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (February 18, 2011)
  • K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (September 18, 2009)
  • K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (November 3, 2006)
  • K061585 — OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (October 5, 2006)
  • K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE C (August 4, 2006)
  • K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (June 26, 2006)
  • K060093 — PRESEP OLIGON OXIMETRY CATHETERS (April 28, 2006)
  • K053609 — PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUT (February 28, 2006)

FDA data resources