Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS

K-Number: K091268 · 2009-09-18

ApplicantHospira, Inc.
Decision Date2009-09-18
Product CodeDQE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR 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 2009-09-18 under 510(k) number K091268. 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 CRITICAL CARE AND ADVANCED SENSOR CATHETERS?

HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is Hospira, Inc.. The 510(k) number is K091268.

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

HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS received FDA 510(k) clearance on 2009-09-18, under 510(k) number K091268.

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

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 36 devices →

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, LLCK062999OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINHospira, Inc.K061585OPTICATH CENTRAL VENOUS OXIMETRY CATHETERHospira, 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.

↑