DYNAFLO BYPASS GRAFT— 510(k) K050049

Name: FDA 510(k) clearance K050049
Creator: U.S. Food and Drug Administration
Published: 2005-01-31

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K050049 for DYNAFLO BYPASS GRAFT, Substantially Equivalent on 2005-01-31. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 2005-01-10
Decision date: 2005-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.