K252402

Substantially Equivalent

Midline Catheter

Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
Product code: PND
Advisory panel: General Hospital
Date received: 2025-07-31
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Adverse events under product code PND

product code PND

Injury: 149
Malfunction: 695
Other: 1
Total: 845

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.