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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
510(k) Number K202751
Device Name TandemHeart Pump and Escort Controller
Applicant
Cardiacassist, Inc.
620 Alpha Dr. Suite 2
Pittsburg,  PA  15238
Applicant Contact Megan Walsh
Correspondent
Cardiacassist, Inc.
620 Alpha Dr. Suite 2
Pittsburg,  PA  15238
Correspondent Contact Megan Walsh
Regulation Number870.4100
Classification Product Code
QNR  
Date Received09/21/2020
Decision Date 03/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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