Medical Device Manufacturer · US , Pittsburgh , PA

Cardiacassist, Inc.

21 submissions · 21 cleared · Since 2000
21
Total
21
Cleared
0
Denied

Cardiacassist, Inc. — FDA 510(k) Submissions

Cardiacassist, Inc. has submitted 21 FDA 510(k) premarket notifications since 2000, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, Pump, Blood, Cardiopulmonary Bypass, Non-roller Type, Blood Pump For Ecmo, Long-term (> 6 Hours) Use, Cannula, Catheter, Control, Pump Speed, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.

21 devices
1–12 of 21
LifeSPARC System
K233736 · QNR Blood Pump For Ecmo,... · Cardiovascular
Jan 2024 58d
ProtekDuo Veno-Venous Cannula Sets
K232480 · PZS Dual Lumen Ecmo Cannula · Cardiovascular
Oct 2023 51d
LifeSPARC System
K232132 · KFM Pump, Blood,... · Cardiovascular
Aug 2023 16d
LifeSPARC System
K211830 · QNR Blood Pump For Ecmo,... · Cardiovascular
Nov 2022 519d
TandemHeart Pump and Escort Controller
K202751 · QNR Blood Pump For Ecmo,... · Cardiovascular
Mar 2021 186d
LifeSPARC Pump, LifeSPARC Controller
K183623 · KFM Pump, Blood,... · Cardiovascular
Jul 2019 195d
ProtekDuo Mini Veno-Venous Cannula Set
K181150 · DWF Catheter, Cannula And... · Cardiovascular
May 2018 24d
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
K162181 · DRE Dilator, Vessel, For... · Cardiovascular
Jan 2017 155d
Protek Solo 24 Fr Venous Cannula Set
K162214 · DWF Catheter, Cannula And... · Cardiovascular
Nov 2016 114d
PROTEK Duo 31 Fr. Veno-Venous Cannula Set
K160257 · DWF Catheter, Cannula And... · Cardiovascular
Mar 2016 32d
TandemLung Oxygenator
K153295 · DTZ Oxygenator,... · Cardiovascular
Feb 2016 105d
TANDEMHEART VENO-VENOUS CANNULA
K140999 · DWF Catheter, Cannula And... · Cardiovascular
Aug 2014 110d
Filters
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