FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
K Number: K022489
·
Decision Oct 9, 2002
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
5
Review Days
72
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 CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
- K Number
- K022489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Summit Medical , Ltd.
- Date Received
- July 29, 2002
- Decision Date
- October 9, 2002
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAC), ordered by most recent decision date.
XTRA Collection sets; XTRA Sequestration set X
FDA 510(k)
FDA Class 2
·Anesthesiology
Aventus Clot Management System
FDA 510(k)
FDA Class 2
·Anesthesiology
XTRA Autotransfusion System (with XTRA Bowl sets)
FDA 510(k)
FDA Class 2
·Anesthesiology
FlowSaver Blood Return System (80-101)
FDA 510(k)
FDA Class 2
·Anesthesiology
FlowSaver Blood Return System
FDA 510(k)
FDA Class 2
·Anesthesiology
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET | Oct 25, 2002 | Substantially Equivalent |