Globe Introducer (601-01001)— 510(k) K250529

Substantially Equivalent

Kardium, Inc.

FDA 510(k) clearance K250529 for Globe Introducer (601-01001), Substantially Equivalent on 2025-06-03. Applicant: Kardium, Inc..

Clearance details

Applicant: Kardium, Inc.
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2025-02-24
Decision date: 2025-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.