OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN

Catheter, Oximeter, Fiber-optic

HOSPIRA, INC.

The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Opticath Central Venous Oximetry Probe With Fluidic Seal With/without Heparin.

Pre-market Notification Details

Device IDK061159
510k NumberK061159
Device Name:OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
ClassificationCatheter, Oximeter, Fiber-optic
Applicant HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest,  IL  60045 -5045
ContactThomas Kozma
Product CodeDQE  
CFR Regulation Number870.1230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductYes
Date Received2006-04-26
Decision Date2006-06-26
Summary:summary

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