510(k) K232207— D·Kutting PTA Scoring Balloon Dilatation Catheter

Substantially Equivalent

Dk Medical Technology Co., Ltd.

Clearance details

Applicant: Dk Medical Technology Co., Ltd.
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2023-07-26
Decision date: 2024-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Adverse events under product code PNO

product code PNO

Malfunction: 1,646
Total: 1,646

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.