FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPS-3000 CARDIOPLEGIA RESERVOIR
K Number: K861102
·
Decision May 28, 1986
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
89
Applicant Total
75
Review Days
65
Basic Information
- Device Name
- CPS-3000 CARDIOPLEGIA RESERVOIR
- K Number
- K861102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- GISH BIOMEDICAL, INC.
- Date Received
- March 24, 1986
- Decision Date
- May 28, 1986
- Product Code
- DTR
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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