FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
K Number: K053000
·
Decision Nov 21, 2005
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
28
Review Days
27
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Basic Information
- Device Name
- HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
- K Number
- K053000
- 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 25, 2005
- Decision Date
- November 21, 2005
- 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 |
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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 |
| 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 |
| K953681 | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET | Jun 4, 1996 | Substantially Equivalent |