FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
K Number: K122811
·
Decision Oct 12, 2012
Classifications
1
FEI Numbers
149
Registration Numbers
150
Same Product Code
137
Applicant Total
84
Review Days
29
Basic Information
- Device Name
- CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
- K Number
- K122811
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC INC.
- Date Received
- September 13, 2012
- Decision Date
- October 12, 2012
- Product Code
- DTL
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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