TandemHeart Pump and Escort Controller— 510(k) K202751

Name: FDA 510(k) clearance K202751
Creator: U.S. Food and Drug Administration
Published: 2021-03-26

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K202751 for TandemHeart Pump and Escort Controller, Substantially Equivalent on 2021-03-26. Applicant: Cardiacassist, Inc.. Device class: 2.

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code QNR
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2020-09-21
Decision date: 2021-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburg, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QNR

product code QNR

Death: 11
Total: 11

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.