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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 the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) 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. The listed applicant is Hospira, Inc.. The 510(k) number is K143612.

When did LifeCare PCA Infusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for LifeCare PCA Infusion System?

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 LifeCare PCA Infusion System?

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

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 Sets

Related Devices (Code: MEA)

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.

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

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

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