APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)— 510(k) K001250
Substantially EquivalentAsahi Medical Co., Ltd.
FDA 510(k) clearance K001250 for APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS), Substantially Equivalent on 2000-08-16. Applicant: Asahi Medical Co., Ltd..
Clearance details
- Applicant
- Asahi Medical Co., Ltd.
- Product code
- Code KDI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Adverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
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.