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FDA 510(k)

AirLife Adult Heated Wire Circuit

K-Number: K153234 · 2016-07-07

ApplicantCarefusion, Inc.
Decision Date2016-07-07
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirLife Adult Heated Wire Circuit is a medical device manufactured by Carefusion, Inc.. It received FDA 510(k) clearance on 2016-07-07 under approval number K153234. 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 Adult Heated Wire Circuit?

AirLife Adult Heated Wire Circuit is a medical device that received FDA 510(k) clearance on 2016-07-07. It is manufactured by Carefusion, Inc.. The 510(k) number is K153234.

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

AirLife Adult Heated Wire Circuit received FDA 510(k) clearance on 2016-07-07, under approval number K153234.

What company makes AirLife Adult Heated Wire Circuit?

AirLife Adult Heated Wire Circuit is manufactured by Carefusion, Inc..

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

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

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Other Devices by Carefusion, Inc.

K151959AirLife Infant Single Limb Heated Wire Circuit K193088MaxZero Extension Sets with Needle-Free Connector(s)

Related Devices (Code: BZE)

K160540FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMFlexicare Medical Limited. K151461Hybernite RTPlastiflex Group NV K151303AirLife Infant Heated Wire CircuitCare Fusion 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.

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