Cardiacassist, Inc. - FDA 510(k) Cleared Devices

Cleared Jan 19, 2024

LifeSPARC System

K233736 · QNR

Cardiovascular · 58d

Cleared Oct 06, 2023

ProtekDuo Veno-Venous Cannula Sets

K232480 · PZS

Cardiovascular · 51d

Cleared Aug 03, 2023

LifeSPARC System

K232132 · KFM

Cardiovascular · 16d

Cleared Nov 15, 2022

LifeSPARC System

K211830 · QNR

Cardiovascular · 519d

Cleared Mar 26, 2021

TandemHeart Pump and Escort Controller

K202751 · QNR

Cardiovascular · 186d

Cleared Jul 09, 2019

LifeSPARC Pump, LifeSPARC Controller

K183623 · KFM

Cardiovascular · 195d

Cleared May 25, 2018

ProtekDuo Mini Veno-Venous Cannula Set

K181150 · DWF

Cardiovascular · 24d

Cleared Jan 06, 2017

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

K162181 · DRE

Cardiovascular · 155d

Cleared Nov 30, 2016

Protek Solo 24 Fr Venous Cannula Set

K162214 · DWF

Cardiovascular · 114d

Cleared Mar 04, 2016

PROTEK Duo 31 Fr. Veno-Venous Cannula Set

K160257 · DWF

Cardiovascular · 32d

Cleared Feb 26, 2016

TandemLung Oxygenator

K153295 · DTZ

Cardiovascular · 105d

Cleared Aug 06, 2014

TANDEMHEART VENO-VENOUS CANNULA

K140999 · DWF

Cardiovascular · 110d