MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711— 510(k) K031700
Substantially EquivalentMedtronic 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. Device class: 2.
Clearance details
- Applicant
- Medtronic Perfusion Systems
- Product code
- Code DTN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, through . 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.