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

FDA 510(k)

AirLife Infant Heated Wire Circuit

K-Number: K151303 · 2016-01-21

ApplicantCare Fusion
Decision Date2016-01-21
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirLife Infant Heated Wire Circuit is a medical device manufactured by Care Fusion. It received FDA 510(k) clearance on 2016-01-21 under approval number K151303. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirLife Infant Heated Wire Circuit?

AirLife Infant Heated Wire Circuit is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by Care Fusion. The 510(k) number is K151303.

When was AirLife Infant Heated Wire Circuit approved by the FDA?

AirLife Infant Heated Wire Circuit received FDA 510(k) clearance on 2016-01-21, under approval number K151303.

What company makes AirLife Infant Heated Wire Circuit?

AirLife Infant Heated Wire Circuit is manufactured by Care Fusion.

What is the FDA product code for AirLife Infant Heated Wire Circuit?

The FDA product code for AirLife Infant Heated Wire Circuit is BZE.

Related Clinical Trials

NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED

Other Devices by Care Fusion

K160437PleurX Peritoneal Catheter System K160450Pleurx Pleural Catheter System K170405BD Curve Ascites Shunt K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle K153748AirLife Misty Finity Nebulizer K201155PleurX Peritoneal Catheter System

View all 14 devices →

Related Devices (Code: BZE)

K153234AirLife Adult Heated Wire CircuitCarefusion, Inc. K160540FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMFlexicare Medical Limited. K151461Hybernite RTPlastiflex Group NV K151959AirLife Infant Single Limb Heated Wire CircuitCarefusion, Inc. K170378AirLife Adult Heated Wire BiPAP/NIV CircuitVyaire Medical K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, 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.

↑