510(k) K221078
K221078 is an FDA 510(k) premarket notification submitted by Sichuan Prius Biotechnology Co., Ltd. for the device "Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use". The FDA issued a decision of Substantially Equivalent on November 21, 2022. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sichuan Prius Biotechnology Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2022
- Date Received
- April 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type