Sterile High-pressure Angiographic Syringes for single-use— 510(k) K201395

Substantially Equivalent

Youwo (Guangzhou) Medical Device Co., Ltd.

FDA 510(k) clearance K201395 for Sterile High-pressure Angiographic Syringes for single-use, Substantially Equivalent on 2020-10-28. Applicant: Youwo (Guangzhou) Medical Device Co., Ltd..

Clearance details

Applicant: Youwo (Guangzhou) Medical Device Co., Ltd.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2020-05-27
Decision date: 2020-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, 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.