FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAEMONETICS 1400 ML THERAPEUTIC BAG
K Number: K810313
·
Decision Mar 31, 1981
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
15
Applicant Total
28
Review Days
54
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Basic Information
- Device Name
- HAEMONETICS 1400 ML THERAPEUTIC BAG
- K Number
- K810313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9100
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Haemonetics Corp.
- Date Received
- February 5, 1981
- Decision Date
- March 31, 1981
- Product Code
- KSR
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | FDA class 2 | Hematology |
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|---|---|---|---|
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| 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 |
| K993581 | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER | Nov 18, 1999 | Substantially Equivalent |