FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUID MANAGEMENT SYSTEM (MODIFIED)
K Number: K860969
·
Decision May 6, 1986
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
28
Review Days
56
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Basic Information
- Device Name
- FLUID MANAGEMENT SYSTEM (MODIFIED)
- K Number
- K860969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Haemonetics Corp.
- Date Received
- March 11, 1986
- Decision Date
- May 6, 1986
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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|---|---|---|---|
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| 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 |
| K993581 | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER | Nov 18, 1999 | Substantially Equivalent |