DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS— 510(k) K102833
Substantially EquivalentFoshan Nanhai Bai HE Medical Technology Co., Ltd.
FDA 510(k) clearance K102833 for DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS, Substantially Equivalent on 2011-11-18. Applicant: Foshan Nanhai Bai HE Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Foshan Nanhai Bai HE Medical Technology Co., Ltd.
- Product code
- Code MPB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code MPB
view all- K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter
- K200426 — Acute Dual Lumen Hemodialysis Catheter
- K192807 — Duo-Flow Side x Side Double Lumen Catheter
- K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- K163458 — Zenysis Short-Term Dialysis Catheter
More clearances from Foshan Nanhai Bai HE Medical Technology Co., Ltd.
view allAdverse events under product code MPB
product code MPB- Death
- 18
- Malfunction
- 1,042
- Total
- 1,060
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.