FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
K Number: K012178
·
Decision Jul 23, 2001
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
3
Review Days
11
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
- FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
- K Number
- K012178
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fresenius Hemotechnology, Inc.
- Date Received
- July 12, 2001
- Decision Date
- July 23, 2001
- 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