FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
K Number: K872895
·
Decision Jan 11, 1988
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
7
Applicant Total
28
Review Days
172
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Basic Information
- Device Name
- HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
- K Number
- K872895
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5530
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Haemonetics Corp.
- Date Received
- July 23, 1987
- Decision Date
- January 11, 1988
- Product Code
- CAL
- 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 |
|---|---|---|---|
| CAL | Laryngoscope, Non-Rigid | FDA class 1 | Anesthesiology |
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| 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 |