510(k) K254223— Next Generation 088 Catheter

Substantially Equivalent

Balt USA, LLC

Clearance details

Applicant: Balt USA, LLC
Product code: Code QJP
Advisory panel: Cardiovascular
Date received: 2025-12-29
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

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.