510(k) K163160
K163160 is an FDA 510(k) premarket notification submitted by Jiangxi Hongda Medical Equipment Group , Ltd. for the device "Sterile Single-use Infusion Set". The FDA issued a decision of Substantially Equivalent on Apr 20, 2017. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Jiangxi Hongda Medical Equipment Group , Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 20, 2017
- Date Received
- Nov 10, 2016
- 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
- 510(k)