FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUSION Vascular Graft
K Number: K153523
·
Decision Feb 16, 2016
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
14
Review Days
69
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Basic Information
- Device Name
- FUSION Vascular Graft
- K Number
- K153523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maquet Cardiovascular, LLC
- Date Received
- December 9, 2015
- Decision Date
- February 16, 2016
- 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 |
Similar 510(k) Clearances
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GORE® PROPATEN® Vascular Graft
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Other Clearances by Maquet Cardiovascular, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K252445 | Fusion Bioline Vascular Graft | Apr 27, 2026 | Substantially Equivalent |
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| K243918 | Vasoview Hemopro 3 Power Supply | Feb 26, 2025 | Substantially Equivalent |
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) | Feb 27, 2024 | Substantially Equivalent |
| K191930 | 7 mm Extended Length Endoscope | Apr 15, 2020 | Substantially Equivalent |
| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord | Sep 17, 2019 | Substantially Equivalent |
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting System | Apr 19, 2016 | Substantially Equivalent |
| K132743 | HARVESTING CANNULA | Dec 3, 2013 | Substantially Equivalent |
| K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT | Nov 14, 2013 | Substantially Equivalent |
| K122612 | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX | Sep 10, 2012 | Substantially Equivalent |