FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
K Number: K022477
·
Decision Oct 25, 2002
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
5
Review Days
88
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
- SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
- K Number
- K022477
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Summit Medical , Ltd.
- Date Received
- July 29, 2002
- Decision Date
- October 25, 2002
- 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
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
ALPHA MICRON 20/40 MICROAGGREGATE FILTER
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Summit Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K173110 | GRAFTSITE | May 18, 2018 | Substantially Equivalent |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | Jul 25, 2017 | Substantially Equivalent |
| K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 | Feb 14, 2003 | Substantially Equivalent |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 | Oct 9, 2002 | Substantially Equivalent |