K222694
Substantially EquivalentEmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- Applicant
- MicroVention, Inc.
- Product code
- NTE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
Adverse events under product code NTE
product code NTE- Death
- 28
- Injury
- 1,348
- Malfunction
- 771
- Total
- 2,147
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.