TandemHeart Pump And Escort Controller

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

CardiacAssist, Inc.

The following data is part of a premarket notification filed by Cardiacassist, Inc. with the FDA for Tandemheart Pump And Escort Controller.

Pre-market Notification Details

Device IDK202751
510k NumberK202751
Device Name:TandemHeart Pump And Escort Controller
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant CardiacAssist, Inc. 620 Alpha Drive, Suite 2 Pittsburgh,  PA  15238
ContactMegan Walsh
CorrespondentMegan Walsh
CardiacAssist, Inc. 620 Alpha Drive, Suite 2 Pittsburgh,  PA  15238
Product CodeQNR
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-03-26

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.