FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
CardioCel 3D
K Number: K170951
·
Decision Apr 28, 2017
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
10
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- CardioCel 3D
- K Number
- K170951
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Admedus Regen Pty, Ltd.
- Date Received
- March 31, 2017
- Decision Date
- April 28, 2017
- Product Code
- PSQ
- 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 |
|---|---|---|---|
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | FDA class 2 | Cardiovascular |
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