APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
FDA 510(k) clearance K001250 · decided 2000-08-16
Clearance details
- K-number
- K001250
- Device name
- APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
- Applicant
- Asahi Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-19
- Decision date
- 2000-08-16
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of ho recall (Z-0790-05) | Asahi Medical Co Ltd | 2005-05-03 |
| Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, A recall (Z-0739-04) | Asahi Medical Co Ltd | 2004-07-20 |