VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)— 510(k) K063217

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K063217 for VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL), Substantially Equivalent on 2007-01-12. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2006-10-24
Decision date: 2007-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

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.