Medical Device Manufacturer · US , Pittsburgh , PA

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

21 submissions · 21 cleared · Since 2000

Total

Cleared

Denied

Cardiacassist, Inc. has 21 FDA 510(k) cleared cardiovascular devices. Based in Pittsburgh, US.

Latest FDA clearance: Jan 2024. Active since 2000.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Cardiacassist, Inc.

21 devices

1-12 of 21

ProtekDuo Veno-Venous Cannula Sets

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

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

FDA 510(k) cleared devices by Cardiacassist, Inc.

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