510(k) K102833
K102833 is an FDA 510(k) premarket notification submitted by Foshan Nanhai Bai HE Medical Technology Co., Ltd. for the device "DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS". The FDA issued a decision of Substantially Equivalent on November 18, 2011. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Foshan Nanhai Bai HE Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2011
- Date Received
- September 29, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Non-Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type