Cardiacassist, Inc. - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
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.
21 devices
Cleared
Jan 19, 2024
LifeSPARC System
Cardiovascular
58d
Cleared
Oct 06, 2023
ProtekDuo Veno-Venous Cannula Sets
Cardiovascular
51d
Cleared
Aug 03, 2023
LifeSPARC System
Cardiovascular
16d
Cleared
Nov 15, 2022
LifeSPARC System
Cardiovascular
519d
Cleared
Mar 26, 2021
TandemHeart Pump and Escort Controller
Cardiovascular
186d
Cleared
Jul 09, 2019
LifeSPARC Pump, LifeSPARC Controller
Cardiovascular
195d
Cleared
May 25, 2018
ProtekDuo Mini Veno-Venous Cannula Set
Cardiovascular
24d
Cleared
Jan 06, 2017
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
Cardiovascular
155d
Cleared
Nov 30, 2016
Protek Solo 24 Fr Venous Cannula Set
Cardiovascular
114d
Cleared
Mar 04, 2016
PROTEK Duo 31 Fr. Veno-Venous Cannula Set
Cardiovascular
32d
Cleared
Feb 26, 2016
TandemLung Oxygenator
Cardiovascular
105d
Cleared
Aug 06, 2014
TANDEMHEART VENO-VENOUS CANNULA
Cardiovascular
110d
Cleared
Feb 12, 2014
15 FR. TANDEMHEART ARTERIAL CANNULA
Cardiovascular
110d
Cleared
Jan 29, 2014
TANDEMHEART FEMORAL VENOUS CANNULA SET
Cardiovascular
100d
Cleared
May 30, 2012
TANDEMHEART FEMORAL ARTERIAL CANNULA SET
Cardiovascular
97d
Cleared
Sep 20, 2011
TANDEMHEART PUMP
Cardiovascular
210d
Cleared
Sep 18, 2008
TANDEMHEART TRANSSEPTAL CANNULA- EF 72
Cardiovascular
27d
Cleared
Aug 22, 2006
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
Cardiovascular
97d
Cleared
Jan 17, 2006
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
Cardiovascular
120d
Cleared
May 23, 2003
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
Cardiovascular
106d
Cleared
Nov 01, 2000
AB-180 XC SYSTEM, MODEL AB-180XC
Cardiovascular
526d