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.. Device class: 2.
Clearance details
- Applicant
- Asahi Medical Co., Ltd.
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code KDI
view allMore clearances from Asahi Medical Co., Ltd.
view all- K041726 — HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
- K013418 — AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
- K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
- K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
- K970650 — ASAHI AM-R SERIES DIALYZERS
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.