ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301— 510(k) K072696

Substantially Equivalent

Shenzhen Ant Hi-Tech Industrial Co., Ltd.

FDA 510(k) clearance K072696 for ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301, Substantially Equivalent on 2008-05-02. Applicant: Shenzhen Ant Hi-Tech Industrial Co., Ltd..

Clearance details

Applicant: Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2007-09-24
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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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.