K024007

Substantially Equivalent

SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J

Applicant: Sunder Biomedical Tech. Co., Ltd.
Product code: FOZ
Advisory panel: General Hospital
Date received: 2002-12-04
Decision date: 2003-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.