FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
VascuCel
K Number: K162579
·
Decision Oct 14, 2016
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
3
Review Days
29
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Basic Information
- Device Name
- VascuCel
- K Number
- K162579
- 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
- September 15, 2016
- Decision Date
- October 14, 2016
- Product Code
- DXZ
- 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | FDA class 2 | Cardiovascular |
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