FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
K Number: K993581
·
Decision Nov 18, 1999
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
28
Review Days
27
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
- HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
- K Number
- K993581
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haemonetics Corp.
- Date Received
- October 22, 1999
- Decision Date
- November 18, 1999
- 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 Haemonetics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Oct 25, 2012 | Substantially Equivalent |
| K120586 | CELL SAVER ELITE | May 22, 2012 | Substantially Equivalent |
| K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | Dec 3, 2010 | Substantially Equivalent |
| K062801 | SMARTSUCTION SOLO DEVICE | Oct 4, 2006 | Substantially Equivalent |
| K061103 | HAEMONETICS 40U RBC FILTER BAG | May 17, 2006 | Substantially Equivalent |
| K053000 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) | Nov 21, 2005 | Substantially Equivalent |
| K052626 | SMARTSUCTION HARMONY DEVICE | Oct 5, 2005 | Substantially Equivalent |
| K043127 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Jan 4, 2005 | Substantially Equivalent |
| K014083 | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM | Jan 8, 2002 | Substantially Equivalent |
| K953681 | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET | Jun 4, 1996 | Substantially Equivalent |