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FDA 510(k)

LifeSPARC Pump, LifeSPARC Controller

K-Number: K183623 · 2019-07-09

ApplicantCardiacassist, Inc.
Decision Date2019-07-09
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeSPARC Pump, LifeSPARC Controller is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2019-07-09 under approval number K183623. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeSPARC Pump, LifeSPARC Controller?

LifeSPARC Pump, LifeSPARC Controller is a medical device that received FDA 510(k) clearance on 2019-07-09. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K183623.

When was LifeSPARC Pump, LifeSPARC Controller approved by the FDA?

LifeSPARC Pump, LifeSPARC Controller received FDA 510(k) clearance on 2019-07-09, under approval number K183623.

What company makes LifeSPARC Pump, LifeSPARC Controller?

LifeSPARC Pump, LifeSPARC Controller is manufactured by Cardiacassist, Inc..

What is the FDA product code for LifeSPARC Pump, LifeSPARC Controller?

The FDA product code for LifeSPARC Pump, LifeSPARC Controller is KFM.

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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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