FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm— 510(k) K152485

Clearance details

Applicant

Ostial Corporation

Product code

Code LOX

Device class

Class 2

Regulation

21 CFR 870.5100

Advisory panel

Cardiovascular

Date received

2015-08-31

Decision date

2016-02-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sunnyvale, CA, US

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Death

190

Injury

1,498

Malfunction

9,670

Total

11,358

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 →