FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
K Number: K896664
·
Decision Jan 24, 1990
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
16
Review Days
61
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Basic Information
- Device Name
- MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
- K Number
- K896664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Asahi Medical Co., Ltd.
- Date Received
- November 24, 1989
- Decision Date
- January 24, 1990
- Product Code
- CAK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | FDA class 2 | General Hospital |
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Other Clearances by Asahi Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K041726 | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX | Jul 23, 2004 | Substantially Equivalent |
| K013418 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY | Jul 9, 2002 | Substantially Equivalent |
| K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) | Aug 16, 2000 | Substantially Equivalent |
| K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | Jul 29, 1999 | Substantially Equivalent |
| 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- | May 17, 1999 | Substantially Equivalent |
| K970650 | ASAHI AM-R SERIES DIALYZERS | Sep 30, 1997 | Substantially Equivalent |
| K914020 | MODIFIED ASAHI PAN-SERIES HEMOFILTERS | Mar 20, 1992 | Substantially Equivalent |
| K901887 | MODIFIED SEPACELL R-SERIES BLOOD FILTERS | Aug 8, 1990 | Substantially Equivalent |
| K896976 | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | Jan 24, 1990 | Substantially Equivalent |
| K892375 | MODIFIED AM-SERIES DIALYZERS | May 18, 1989 | Substantially Equivalent |