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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) 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. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K202751.

When did TandemHeart Pump and Escort Controller receive FDA 510(k) clearance?

TandemHeart Pump and Escort Controller received FDA 510(k) clearance on 2021-03-26, under 510(k) number K202751.

Who is the listed applicant for TandemHeart Pump and Escort Controller?

The FDA 510(k) record lists Cardiacassist, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TandemHeart Pump and Escort Controller?

The FDA product code for TandemHeart Pump and Escort Controller is QNR.

Other records listing Cardiacassist, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250199VitalFlow ConsoleMedtronic, Inc.K234118CentriMag™ Acute Circulatory Support SystemABBOTT MEDICALK233736LifeSPARC SystemCardiacassist, Inc.K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K222038CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemAbbott (Formerly Thoratec Corporation)

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.

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