EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)— 510(k) K222694

Substantially Equivalent

MicroVention, Inc.

FDA 510(k) clearance K222694 for EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190), Substantially Equivalent on 2023-04-27. Applicant: MicroVention, Inc..

Clearance details

Applicant: MicroVention, Inc.
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2022-09-06
Decision date: 2023-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NTE

product code NTE

Death: 28
Injury: 1,348
Malfunction: 771
Total: 2,147

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.