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510(k) K062999

OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN by Hospira, Inc. — Product Code DQE

K062999 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN". The FDA issued a decision of Substantially Equivalent on Nov 3, 2006. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Hospira, Inc. has 44 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 3, 2006
Date Received
Oct 2, 2006
Clearance Type
Special
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
510(k)

Other clearances by Hospira, Inc.

  • K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (Mar 28, 2017)
  • K161036 — Hospira Extension Set, Hospira Primary Set (Jan 6, 2017)
  • K160492 — Hospira Sapphire Sets (Dec 6, 2016)
  • K160870 — Hospira Administration Sets (Jun 1, 2016)
  • K143612 — LifeCare PCA Infusion System (Apr 8, 2016)
  • K143087 — Hospira Blood Set (Mar 4, 2015)
  • K143015 — Hospira Primary Sets (Feb 25, 2015)
  • K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0… (Jan 16, 2015)
  • K142622 — IV Administration (Jan 15, 2015)
  • K142974 — Extension Sets (Jan 9, 2015)

Other clearances for product code DQE

  • K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry… (Feb 20, 2018)
  • K160645 — PreSep Oligon Oximetry Catheter (Jun 16, 2016)
  • K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY… (Jul 2, 2014)
  • K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (Feb 18, 2011)
  • K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (Sep 18, 2009)
  • K061585 — OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (Oct 5, 2006)
  • K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE… (Aug 4, 2006)
  • K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (Jun 26, 2006)
  • K060093 — PRESEP OLIGON OXIMETRY CATHETERS (Apr 28, 2006)
  • K053609 — PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC… (Feb 28, 2006)

FDA data resources