FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K Number: K873666
·
Decision Jan 6, 1988
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
28
Review Days
118
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Basic Information
- Device Name
- PALL LEUKOCYTE REMOVAL FILTER, BLOOD
- K Number
- K873666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pall Biomedical Products Co.
- Date Received
- September 10, 1987
- Decision Date
- January 6, 1988
- 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 Pall Biomedical Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Jan 9, 1997 | Substantially Equivalent |
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | Apr 22, 1996 | Substantially Equivalent |
| K905794 | PALL 3N1 FILTER | Jun 13, 1991 | Substantially Equivalent |
| K902518 | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE | Oct 16, 1990 | Substantially Equivalent |
| K884534 | PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER | Jan 24, 1989 | Substantially Equivalent |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Feb 29, 1988 | Substantially Equivalent |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Feb 29, 1988 | Substantially Equivalent |
| K873667 | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | Jan 6, 1988 | Substantially Equivalent |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Dec 30, 1987 | Substantially Equivalent |
| K853987 | PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE | Dec 11, 1985 | Substantially Equivalent |