FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Asahi REXEED-S Series Dialyzer
K Number: K153344
·
Decision Dec 17, 2015
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- Asahi REXEED-S Series Dialyzer
- K Number
- K153344
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asahi Kasei Medical Co., Ltd.
- Date Received
- November 19, 2015
- Decision Date
- December 17, 2015
- Product Code
- KDI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Asahi Kasei Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K162248 | Asahi ViE-U Series Dialyzer | May 3, 2017 | Substantially Equivalent |
| K121409 | ASAHI REXEED-SX/LX SERIES DIALYZER | Feb 6, 2013 | Substantially Equivalent |
| K082515 | ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX | Oct 3, 2008 | Substantially Equivalent |
| K051187 | REXEED SERIES DIALYZERS | Jun 8, 2005 | Substantially Equivalent |