Cleared Traditional

LifeSPARC System

K211830 · Cardiacassist, Inc. · Cardiovascular

Nov 2022

Decision

519d

Days

Class 2

Risk

About This 510(k) Submission

K211830 is an FDA 510(k) clearance for the LifeSPARC System, a Blood Pump For Ecmo, Long-term (> 6 Hours) Use (Class II — Special Controls, product code QNR), submitted by Cardiacassist, Inc. (Pittsburg, US). The FDA issued a Cleared decision on November 15, 2022, 519 days after receiving the submission on June 14, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K211830 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2021
Decision Date	November 15, 2022
Days to Decision	519 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QNR — Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4100
Definition	A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure Where Other Available Treatment Options Have Failed And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.