FDA 510(k)

HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS

K-Number: K061450 · 2006-08-04

Decision Date2006-08-04

Product CodeDQE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2006-08-04 under 510(k) number K061450. The device is classified under product code DQE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS?

HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Hospira, Inc.. The 510(k) number is K061450.

When did HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS receive FDA 510(k) clearance?

HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS received FDA 510(k) clearance on 2006-08-04, under 510(k) number K061450.

Who is the listed applicant for HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS?

The FDA 510(k) record lists Hospira, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS?

The FDA product code for HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS is DQE.

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Other records listing Hospira, Inc. as applicant

K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module K161036Hospira Extension Set, Hospira Primary Set K160492Hospira Sapphire Sets K160870Hospira Administration Sets K143612LifeCare PCA Infusion System K132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML

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Related Devices (Code: DQE)

K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC K110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLC K091268HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.K062999OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINHospira, Inc.K061585OPTICATH CENTRAL VENOUS OXIMETRY CATHETERHospira, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.