BARD SAFE SAMPLING DEVICE— 510(k) K925446

Clearance details

Applicant

C.R. Bard, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1992-10-28

Decision date

1993-07-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Covington, GA, US

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Death

28

Injury

1,517

Malfunction

23,981

Other

18

Total

25,544

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 →