FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K Number: K960993
·
Decision Apr 22, 1996
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
28
Review Days
41
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
- K Number
- K960993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pall Biomedical Products Co.
- Date Received
- March 12, 1996
- Decision Date
- April 22, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAK), ordered by most recent decision date.
HAEMONETICS 40U RBC FILTER BAG
FDA 510(k)
FDA Class 2
·General Hospital
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
NEOCARE 20 MICRON BLOOD FILTER
FDA 510(k)
FDA Class 2
·General Hospital
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
FDA 510(k)
FDA Class 2
·General Hospital
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
FDA 510(k)
FDA Class 2
·General Hospital
FENWAL 40 MICRON TRANSFUSION FILTER
FDA 510(k)
FDA Class 2
·General Hospital
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 |
| 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 |
| K873666 | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | 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 |