SIVR56-T KIT— 510(k) K133994

Clearance details

Applicant

Barco N.V.

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

2013-12-26

Decision date

2014-12-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kortrijk, BE

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Death

2

Total

2

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 →