510(k) K202796
K202796 is an FDA 510(k) premarket notification submitted by Jiangxi Sanxin Medtec Co., Ltd. for the device "SANSIN Tubing Sets for Hemodialysis". The FDA issued a decision of Substantially Equivalent on September 6, 2021. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Jiangxi Sanxin Medtec Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2021
- Date Received
- September 23, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type