Liverty TIPS Access Set— 510(k) K221440

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K221440 for Liverty TIPS Access Set, Substantially Equivalent on 2022-05-31. Applicant: Bard Peripheral Vascular, Inc..

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2022-05-17
Decision date: 2022-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.