FDA.reportPublic FDA data

Fusion Vascular Grafts

Primary DI
00384409005621
Brand
Fusion Vascular Grafts
Company
MAQUET CARDIOVASCULAR LLC
Model
M002015010810
Catalog number
M002015010810
Device description
Fusion 10mm-80cm unsupp peripheral graft
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131778000FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFTMaquet Cardiovascular, LLC2013-11-14DSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384409005621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384409005621003844090056213844090056210384409005621

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftA sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length80Centimeter
Lumen/Inner Diameter10Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Controlled Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-880-2874cssurgery@maquet.com

Regulatory Flags#

DUNS number
022348156
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384409005546Fusion Vascular GraftsM002015010260M0020150102602015-10-24
00384409005553Fusion Vascular GraftsM002015010410M0020150104102015-10-24
00384409005560Fusion Vascular GraftsM002015010450M0020150104502015-10-24
00384409005577Fusion Vascular GraftsM002015010460M0020150104602015-10-24
00384409005584Fusion Vascular GraftsM002015010470M0020150104702015-10-24
00384409005591Fusion Vascular GraftsM002015010480M0020150104802015-10-24
00384409005607Fusion Vascular GraftsM002015010660M0020150106602015-10-24
00384409005614Fusion Vascular GraftsM002015010680M0020150106802015-10-24
00384409005638Fusion Vascular GraftsM002015010850M0020150108502015-10-24
00384409005645Fusion Vascular GraftsM002015010860M0020150108602015-10-24
00384409005652Fusion Vascular GraftsM002015010870M0020150108702015-10-24
00384409005669Fusion Vascular GraftsM002015010880M0020150108802015-10-24
00384409005676Fusion Supported Vascular GraftsM002015030410M0020150304102015-10-24
00384409005683Fusion Supported Vascular GraftsM002015030450M0020150304502015-10-24
00384409005690Fusion Supported Vascular GraftsM002015030460M0020150304602015-10-24
00384409005706Fusion Supported Vascular GraftsM002015030470M0020150304702015-10-24
00384409005713Fusion Supported Vascular GraftsM002015030480M0020150304802015-10-24
00607567700376Vasoview EVH Accsessory PackVH-2004VH-20042016-09-24
00607567700772Active Return Cord non-sterileC-1838C-18382016-09-24
00607567700789BiPolar CableC-2838C-28382016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00733132600038GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600052GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600076GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600090GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132605354GORE ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607068GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607129GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607143GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607150GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607174GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607181GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607211GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607228GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607235GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607242GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607259GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607266GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607273GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607280GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607297GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607303GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611508GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611539GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611546GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13