ARTIMES BALLOON DILATATION CATHETER— 510(k) K141025

Substantially Equivalent

Brosmed Medical

FDA 510(k) clearance K141025 for ARTIMES BALLOON DILATATION CATHETER, Substantially Equivalent on 2014-09-12. Applicant: Brosmed Medical.

Clearance details

Applicant: Brosmed Medical
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 2014-04-21
Decision date: 2014-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, Guangdong, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.