B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT— 510(k) K955381

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K955381 for B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT, Substantially Equivalent on 1996-02-21. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1995-11-24
Decision date: 1996-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.