BRAUN MANIFOLD— 510(k) K942391

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K942391 for BRAUN MANIFOLD, Substantially Equivalent on 1995-06-21. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1994-05-19
Decision date: 1995-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.