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

Clearance details

Device name as filed

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

Applicant

MicroVention, Inc.

Product code

Code NTE

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2022-09-06

Decision date

2023-04-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Aliso Viejo, CA, US

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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 →