ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE— 510(k) K090905

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K090905 for ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE, Substantially Equivalent on 2009-04-27. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2009-04-01
Decision date: 2009-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Allentown, PA, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.