FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-CONSOLE, MODEL 560
K Number: K070286
·
Decision May 22, 2007
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
36
Applicant Total
33
Review Days
113
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Basic Information
- Device Name
- BIO-CONSOLE, MODEL 560
- K Number
- K070286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic
- Date Received
- January 29, 2007
- Decision Date
- May 22, 2007
- Product Code
- DWA
- 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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