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FDA 510(k)

OPTICATH CENTRAL VENOUS OXIMETRY CATHETER

K-Number: K061585 · 2006-10-05

ApplicantHospira, Inc.
Decision Date2006-10-05
Product CodeDQE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTICATH CENTRAL VENOUS OXIMETRY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K061585. 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 OPTICATH CENTRAL VENOUS OXIMETRY CATHETER?

OPTICATH CENTRAL VENOUS OXIMETRY CATHETER is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Hospira, Inc.. The 510(k) number is K061585.

When did OPTICATH CENTRAL VENOUS OXIMETRY CATHETER receive FDA 510(k) clearance?

OPTICATH CENTRAL VENOUS OXIMETRY CATHETER received FDA 510(k) clearance on 2006-10-05, under 510(k) number K061585.

Who is the listed applicant for OPTICATH CENTRAL VENOUS OXIMETRY CATHETER?

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 OPTICATH CENTRAL VENOUS OXIMETRY CATHETER?

The FDA product code for OPTICATH CENTRAL VENOUS OXIMETRY CATHETER is DQE.

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Other records listing Hospira, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleK161036Hospira Extension Set, Hospira Primary SetK160492Hospira Sapphire SetsK160870Hospira Administration SetsK143612LifeCare PCA Infusion SystemK132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML

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Related Devices (Code: DQE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLCK160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLCK110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLCK091268HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.K062999OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINHospira, Inc.K061450HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERSHospira, Inc.

Official Source

View on FDA Database →

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

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