Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use— 510(k) K221078
Substantially EquivalentSichuan Prius Biotechnology Co., Ltd.
FDA 510(k) clearance K221078 for Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use, Substantially Equivalent on 2022-11-21. Applicant: Sichuan Prius Biotechnology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Sichuan Prius Biotechnology Co., Ltd.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yibin, CN
Recent devices under product code FPA
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- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Sichuan Prius Biotechnology Co., Ltd.
view allAdverse 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, through . 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.