MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF— 510(k) K914742
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K914742 for MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF, Substantially Equivalent on 1991-12-04. Applicant: Medtronic Vascular.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code DTR
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Adverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
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.