FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANTA GRAFT (<6MM)
K Number: K992958
·
Decision Oct 1, 1999
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
20
Applicant Total
63
Review Days
29
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Basic Information
- Device Name
- ADVANTA GRAFT (<6MM)
- K Number
- K992958
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Atrium Medical Corp.
- Date Received
- September 2, 1999
- Decision Date
- October 1, 1999
- Product Code
- DYF
- 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 |
|---|---|---|---|
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | FDA class 2 | Cardiovascular |
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| K090909 | C-QUR V -PATCH MESH | Jun 4, 2009 | Substantially Equivalent |
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