FDA.reportPublic FDA data

Axius Coronary Shunt

Primary DI
00607567700697
Brand
Axius Coronary Shunt
Company
MAQUET CARDIOVASCULAR LLC
Model
OF-1500L
Catalog number
OF-1500L
Device description
Axius Coronary Shunt, Long Length
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010117000GUIDANT AXIUS CORONARY SHUNTCardiothoracic Systems, Inc.2001-04-04DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20607567700691PackageGS15In Commercial Distribution
00607567700697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2060756770069120607567700691
00607567700697006075677006976075677006970607567700697

GMDN Terms#

Term, Definition table
TermDefinition
Surgical intravascular shuntA sterile device designed to temporarily channel (shunt) intravascular blood through a vascular anastomosis, primarily to control bleeding and enable distal perfusion during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a hollow shaft with atraumatic dilations/bulbs on either end. The shaft is inserted into the lumen of the blood vessel via a small incision at the surgical site allowing blood to flow distal to the site of anastomosis. It is typically made of silicone elastomer and polyester radiopaque materials and is removed upon completion of the intervention. It is available in a range of diameters. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.5Millimeter

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

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
00384409005621Fusion Vascular GraftsM002015010810M0020150108102015-10-24
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

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Primary DI, Brand, Company table
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