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..
Clearance details
- Applicant
- Foshan Nanhai Bai HE Medical Technology Co., Ltd.
- Product code
- Code MPB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Adverse 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.