MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711— 510(k) K031700

Substantially Equivalent

Medtronic Perfusion Systems

FDA 510(k) clearance K031700 for MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711, Substantially Equivalent on 2003-08-29. Applicant: Medtronic Perfusion Systems.

Clearance details

Applicant: Medtronic Perfusion Systems
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2003-06-02
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.