Cleared Special

LifeSPARC System

K232132 · Cardiacassist, Inc. · Cardiovascular
Aug 2023
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K232132 is an FDA 510(k) clearance for the LifeSPARC System, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 3, 2023, 16 days after receiving the submission on July 18, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.

Submission Details

510(k) Number K232132 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2023
Decision Date August 03, 2023
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4360

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