Infusion Sets for Single Use with Needles— 510(k) K221069
Substantially EquivalentSichuan 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.. Device class: 2.
Clearance details
- Applicant
- Sichuan Prius Biotechnology Co., Ltd.
- Product code
- Product 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
view all- K260261 — Gravity Blood Sets with 200µm Filter
- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
More clearances from Sichuan Prius Biotechnology Co., Ltd.
view all- K221075 — Infusion Sets for Single Use
- K221078 — Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
- K221066 — Sterile Hypodermic Needles for Single Use
- K221068 — Sterile Hypodermic Syringes for Single Use with Needles
- K221073 — Sterile Hypodermic Syringes for Single Use with Safety Needles
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, 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.