FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANTA GRAFT
K Number: K992441
·
Decision Aug 20, 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
- K Number
- K992441
- 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
- July 22, 1999
- Decision Date
- August 20, 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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| K113112 | CLEARWAY RX NB CATHETER | Nov 17, 2011 | Substantially Equivalent |
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| K093431 | CLEARWAY OTW MODEL 85912 | Apr 20, 2010 | Substantially Equivalent |
| K100076 | ATRIUM C-QUR OVT MESH | Jan 26, 2010 | Substantially Equivalent |
| K090909 | C-QUR V -PATCH MESH | Jun 4, 2009 | Substantially Equivalent |
| K082748 | ATRIUM PROLITE S MESH | Jan 14, 2009 | Substantially Equivalent |
| K081718 | EXPRESS CHEST DRAIN | Jul 25, 2008 | Substantially Equivalent |