BRAUN DIACAN(R) FISTULA NEEDLES— 510(k) K945850

Substantially Equivalent

B. Braun of America, Inc.

FDA 510(k) clearance K945850 for BRAUN DIACAN(R) FISTULA NEEDLES, Substantially Equivalent on 1995-10-06. Applicant: B. Braun of America, Inc..

Clearance details

Applicant: B. Braun of America, Inc.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1994-11-30
Decision date: 1995-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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Adverse events under product code FIE

product code FIE

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.