Identity
- Trade Name
- Fusion Vascular Grafts FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- Fusion 8mm-60cm Unsupp Peripheral Graft FDA UDI
- Model / Reference
- M002015010680 FDA UDI
- Description
- Fusion 8mm-60cm Unsupp Peripheral Graft FDA UDI
Identifiers
- Catalog Number
- M002015010680 FDA UDI
- Primary DI / UDI-DI
- 00384409005614 FDA UDI
- 510(k) Number
- K131778 FDA UDI
- FDA Product Code
- DSY FDA UDI
- GMDN Term
- Synthetic vascular graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Centimeter FDA UDILumen/Inner Diameter — 8 Millimeter FDA UDI
Category: Synthetic vascular graft
Fusion Vascular Grafts by Maquet Cardiovascular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic vascular graft.
- Gelweave™ — VASCUTEK LTD · Class II
- GORE PROPATEN Vascular Graft Pediatric Shunt — W. L. GORE & ASSOCIATES, INC · Class II
- Gelweave™ — VASCUTEK LTD · Class II
- COOK — William Cook Europe ApS · Class III
- Gelweave™ — VASCUTEK LTD · Class II
- Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
- ADVANTA SLIDER GDS — Atrium Medical Corp. · Class II
- Gelweave Vascular Prostheses — VASCUTEK LTD · Class II
Cleared under the same submission
K131778 also covers:
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
- Fusion Bioline Supported Vascular Grafts — Maquet Cardiovascular LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Maquet Cardiovascular LLC
Sources (1)
- FDA UDI b431944b-1aa3-4620-90b4-773207e3aae2 38 fields · synced Jun 1, 2026