FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS
K Number: K855251
·
Decision Feb 4, 1986
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
13
Review Days
36
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Basic Information
- Device Name
- MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS
- K Number
- K855251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Advocacy International, Ltd.
- Date Received
- December 30, 1985
- Decision Date
- February 4, 1986
- 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 Advocacy International, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K874027 | LIPASE UV [TOYO] | May 27, 1988 | Substantially Equivalent |
| K873792 | SEPACELL R-500 AND SEPACELL R-500A | Jan 19, 1988 | Substantially Equivalent |
| K855212 | ASAHI AM SERIES DIALYZERS | Jan 21, 1986 | Substantially Equivalent |
| K854259 | SEPACELL R-500 & SEPACELL R-500A | Jan 8, 1986 | Substantially Equivalent |
| K842103 | TOYO JOZO URIC ACID TEST | Aug 12, 1984 | Substantially Equivalent |
| K842104 | TOYO JOZO G-GTP TEST | Aug 10, 1984 | Substantially Equivalent |
| K830183 | ASAHI HOLLOW FIBER KIDNEYS NR SERIES | Mar 17, 1983 | Substantially Equivalent |
| K830231 | ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES | Mar 17, 1983 | Substantially Equivalent |
| K823733 | EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR | Jan 14, 1983 | Substantially Equivalent |
| K813037 | FLOWGUARD CATHETERS & CANNALAE | Dec 14, 1981 | Substantially Equivalent |