BRAUN HEMODIALYSIS CATHETER— 510(k) K952660

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code MPB

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

1995-06-12

Decision date

1996-09-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

So. San Francisco, CA, US

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Death

18

Malfunction

1,042

Total

1,060

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 →