Cleared Traditional

LifeSPARC Pump, LifeSPARC Controller

K183623 · Cardiacassist, Inc. · Cardiovascular
Jul 2019
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K183623 is an FDA 510(k) clearance for the LifeSPARC Pump, LifeSPARC Controller, 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 July 9, 2019, 195 days after receiving the submission on December 26, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.

Submission Details

510(k) Number K183623 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2018
Decision Date July 09, 2019
Days to Decision 195 days
Submission Type Traditional
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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