High Pressure Tubing— 510(k) K232388

Substantially Equivalent

Ningbo Dizegens Medical Science Co.,Ltd

FDA 510(k) clearance K232388 for High Pressure Tubing, Substantially Equivalent on 2023-11-21. Applicant: Ningbo Dizegens Medical Science Co.,Ltd.

Clearance details

Applicant: Ningbo Dizegens Medical Science Co.,Ltd
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2023-08-09
Decision date: 2023-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.