FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K Number: K132972
·
Decision Oct 28, 2013
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
209
Review Days
35
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Basic Information
- Device Name
- AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
- K Number
- K132972
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- September 23, 2013
- Decision Date
- October 28, 2013
- Product Code
- DTN
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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