Micro Catheter— 510(k) K243534

Substantially Equivalent

Suzhou Zenith Vascular SciTech Limited

FDA 510(k) clearance K243534 for Micro Catheter, Substantially Equivalent on 2025-07-30. Applicant: Suzhou Zenith Vascular SciTech Limited.

Clearance details

Applicant: Suzhou Zenith Vascular SciTech Limited
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2024-11-15
Decision date: 2025-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.