FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATRIUM FLIXENE IFG VASCULAR GRAFT
K Number: K122138
·
Decision Aug 17, 2012
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
63
Review Days
29
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Basic Information
- Device Name
- ATRIUM FLIXENE IFG VASCULAR GRAFT
- K Number
- K122138
- 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 19, 2012
- Decision Date
- August 17, 2012
- Product Code
- DSY
- 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | FDA class 2 | Cardiovascular |
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Other Clearances by Atrium Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130131 | EDRAIN CHEST DRAINAGE SYSTEM | Feb 28, 2013 | Substantially Equivalent |
| K121070 | C-QUR RPM MESH | Apr 26, 2012 | Substantially Equivalent |
| K113112 | CLEARWAY RX NB CATHETER | Nov 17, 2011 | Substantially Equivalent |
| K102596 | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT | Oct 5, 2010 | Substantially Equivalent |
| 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 |
| K080688 | C-QUR LITE MESH V-PATCH | Apr 16, 2008 | Substantially Equivalent |