Cleared Traditional

LifeSPARC System

K233736 · Cardiacassist, Inc. · Cardiovascular

Jan 2024

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K233736 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. (Pittsburgh, US). The FDA issued a Cleared decision on January 19, 2024, 58 days after receiving the submission on November 22, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K233736 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2023
Decision Date	January 19, 2024
Days to Decision	58 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.