DEVICE: Fusion Bioline Vascular Grafts (00384409005799)
Device Identifier (DI) Information
Fusion Bioline Vascular Grafts
M00201501026B0
In Commercial Distribution
M00201501026B0
MAQUET CARDIOVASCULAR LLC
M00201501026B0
In Commercial Distribution
M00201501026B0
MAQUET CARDIOVASCULAR LLC
Fusion Bioline 6mm-20cm Unsupp Periphera
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35281 | Synthetic vascular graft |
An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131778 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at Controlled Room Temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 20 Centimeter |
Lumen/Inner Diameter: 6 Millimeter |
Device Record Status
8b77007b-f75f-423c-a1eb-1c1835eed0cb
February 05, 2021
4
October 24, 2015
February 05, 2021
4
October 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
888-880-2874
cssurgery@maquet.com
cssurgery@maquet.com