FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
MAXIFLO, TAPERFLO
K Number: K092863
·
Decision Oct 8, 2009
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
26
Review Days
21
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Basic Information
- Device Name
- MAXIFLO, TAPERFLO
- K Number
- K092863
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vascutek, Ltd.
- Date Received
- September 17, 2009
- Decision Date
- October 8, 2009
- 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 Vascutek, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241550 | Gelweave Vascular Prostheses | Feb 27, 2025 | Substantially Equivalent |
| K241070 | Gelsoft Plus Vascular Prostheses | Nov 15, 2024 | Substantially Equivalent |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | Apr 6, 2021 | Substantially Equivalent |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Jul 8, 2020 | Substantially Equivalent |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | Jul 14, 2017 | Substantially Equivalent |
| K162794 | Gelweave Vascular Grafts | Jun 30, 2017 | Substantially Equivalent |
| K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS | Jan 7, 2010 | Substantially Equivalent |
| K091778 | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS | Aug 31, 2009 | Substantially Equivalent |
| K090987 | VASCUTEK BRANCHED GELWEAVE | Jun 19, 2009 | Substantially Equivalent |
| K081560 | VASCUTEK CANNULA GRAFT, MODEL CGS2008S | Feb 10, 2009 | Substantially Equivalent |