Cleared Special

IMPELLA CONTROLLER WITH FLOW CONTROL

K110845 · Abiomed, Inc. · Cardiovascular
Apr 2011
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K110845 is an FDA 510(k) clearance for the IMPELLA CONTROLLER WITH FLOW CONTROL, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on April 27, 2011, 30 days after receiving the submission on March 28, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.

Submission Details

510(k) Number K110845 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2011
Decision Date April 27, 2011
Days to Decision 30 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

Similar Devices — KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 83
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
K251762 · Spectrum Medical S.R.L. · Aug 2025
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
K250326 · Spectrum Medical S.R.L. · Jun 2025
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
K233091 · Qura S.R.L · Oct 2023
LifeSPARC System
K232132 · Cardiacassist, Inc. · Aug 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
K220842 · Qura S.R.L · May 2023
Capiox iCP Centrifugal Pump
K200091 · Terumo Cardiovascular Systems Corporation · Nov 2021