Infusion Sets for Single Use with Needles— 510(k) K221069

Substantially Equivalent

Sichuan Prius Biotechnology Co., Ltd.

FDA 510(k) clearance K221069 for Infusion Sets for Single Use with Needles, Substantially Equivalent on 2022-11-21. Applicant: Sichuan Prius Biotechnology Co., Ltd..

Clearance details

Applicant: Sichuan Prius Biotechnology Co., Ltd.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2022-04-12
Decision date: 2022-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yibin, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.