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510(k) K061159

OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN by Hospira, Inc. — Product Code DQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2006
Date Received
April 26, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Hospira, Inc.

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  • K161036 — Hospira Extension Set, Hospira Primary Set (January 6, 2017)
  • K160492 — Hospira Sapphire Sets (December 6, 2016)
  • K160870 — Hospira Administration Sets (June 1, 2016)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K143087 — Hospira Blood Set (March 4, 2015)
  • K143015 — Hospira Primary Sets (February 25, 2015)
  • K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODU (January 16, 2015)
  • K142622 — IV Administration (January 15, 2015)
  • K142974 — Extension Sets (January 9, 2015)

Other clearances for product code DQE

  • K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Ce (February 20, 2018)
  • K160645 — PreSep Oligon Oximetry Catheter (June 16, 2016)
  • 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)
  • K060093 — PRESEP OLIGON OXIMETRY CATHETERS (April 28, 2006)
  • K053609 — PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUT (February 28, 2006)