TandemHeart Pump and Escort Controller
K-Number: K202751 · 2021-03-26
ApplicantCardiacassist, Inc.
Decision Date2021-03-26
Product CodeQNR
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
TandemHeart Pump and Escort Controller is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2021-03-26 under approval number K202751. The device is classified under product code QNR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TandemHeart Pump and Escort Controller?
TandemHeart Pump and Escort Controller is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K202751.
When was TandemHeart Pump and Escort Controller approved by the FDA?
TandemHeart Pump and Escort Controller received FDA 510(k) clearance on 2021-03-26, under approval number K202751.
What company makes TandemHeart Pump and Escort Controller?
TandemHeart Pump and Escort Controller is manufactured by Cardiacassist, Inc..
What is the FDA product code for TandemHeart Pump and Escort Controller?
The FDA product code for TandemHeart Pump and Escort Controller is QNR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.