Cleared Traditional

TandemHeart Pump and Escort Controller

K202751 · Cardiacassist, Inc. · Cardiovascular

Mar 2021

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K202751 is an FDA 510(k) clearance for the TandemHeart Pump and Escort Controller, a Blood Pump For Ecmo, Long-term (> 6 Hours) Use (Class II — Special Controls, product code QNR), submitted by Cardiacassist, Inc. (Pittsburg, US). The FDA issued a Cleared decision on March 26, 2021, 186 days after receiving the submission on September 21, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K202751 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2020
Decision Date	March 26, 2021
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QNR — Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4100
Definition	A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure Where Other Available Treatment Options Have Failed And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.