K082439

Substantially Equivalent

DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT

Applicant: Shandong Weigao Medical Polymer Co., Ltd.
Product code: DXT
Advisory panel: Cardiovascular
Date received: 2008-08-25
Decision date: 2009-03-23
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.