SOFT TIP EPIDURAL CATHETER KIT— 510(k) K971233

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code CAZ

Device class

Class 2

Regulation

21 CFR 868.5140

Advisory panel

Anesthesiology

Date received

1997-04-02

Decision date

1997-10-17

Decision

Unknown

Clearance type

Traditional

Location

Bethlehem, PA, US

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Injury

145

Malfunction

942

Other

1

Total

1,088

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 →