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FDA 510(k)

LifeCare PCA Infusion System

K-Number: K143612 · 2016-04-08

ApplicantHospira, Inc.
Decision Date2016-04-08
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LifeCare PCA Infusion System is a medical device manufactured by Hospira, Inc.. It received FDA 510(k) clearance on 2016-04-08 under approval number K143612. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeCare PCA Infusion System?

LifeCare PCA Infusion System is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Hospira, Inc.. The 510(k) number is K143612.

When was LifeCare PCA Infusion System approved by the FDA?

LifeCare PCA Infusion System received FDA 510(k) clearance on 2016-04-08, under approval number K143612.

What company makes LifeCare PCA Infusion System?

LifeCare PCA Infusion System is manufactured by Hospira, Inc..

What is the FDA product code for LifeCare PCA Infusion System?

The FDA product code for LifeCare PCA Infusion System is MEA.

Related Clinical Trials

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Other Devices by Hospira, Inc.

K160492Hospira Sapphire Sets K160870Hospira Administration Sets K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module K161036Hospira Extension Set, Hospira Primary Set

Related Devices (Code: MEA)

K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)Smiths Medical Ads, 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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