HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
FDA 510(k) clearance K041726 · decided 2004-07-23
Clearance details
- K-number
- K041726
- Device name
- HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
- Applicant
- Asahi Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-25
- Decision date
- 2004-07-23
- Days to decision
- 28 days
- Clearance type
- Special
- 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 Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer co recall (Z-0171-2007) | Asahi Medical Co., Ltd | 2006-11-14 |