FDA.reportPublic FDA data

Cannula Graft™

Primary DI
05037881009537
Brand
Cannula Graft™
Company
VASCUTEK LTD
Model
CGS2008S
Catalog number
CGS2008S
Device description
Cannula Graft PVC Cannula with Gelatin Sealed ePTFE Vascular Prosthesis
Published
2015-10-24
Public version status
Update
Distribution status
Not 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
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081560000VASCUTEK CANNULA GRAFT, MODEL CGS2008SVascutek, Ltd.2009-02-10DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05037881009537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05037881009537050378810095375037881009537

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, arterialA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length50Centimeter
Lumen/Inner Diameter8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-3786tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
229053087
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05037881184883Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184890Gelweave Vascular Prostheses73261288/10QRME73261288/10QRME2026-05-22
05037881184906Gelweave Vascular Prostheses73281288/10QRME73281288/10QRME2026-05-22
05037881184913Gelweave Vascular Prostheses73301288/10QRME73301288/10QRME2026-05-22
05037881184920Gelweave Vascular Prostheses73321288/10QRME73321288/10QRME2026-05-22
05037881184937Gelweave Vascular Prostheses73341288/10QRME73341288/10QRME2026-05-22
05037881026626Thoraflex™ HybridTHP2224X100ATHP2224X100A2022-05-31
05037881026695Thoraflex™ HybridTHP2426X100ATHP2426X100A2022-05-31
05037881026725Thoraflex™ HybridTHP3032X100ATHP3032X100A2022-05-31
05037881026756Thoraflex™ HybridTHP3038X100ATHP3038X100A2022-05-31
05037881026800Thoraflex™ HybridTHP2628X150ATHP2628X150A2022-05-31
05037881026848Thoraflex™ HybridTHP3036X150ATHP3036X150A2022-05-31
05037881026923Thoraflex™ HybridTHA2830X100ATHA2830X100A2022-05-31
05037881026947Thoraflex™ HybridTHA3034X100ATHA3034X100A2022-05-31
05037881027029Thoraflex™ HybridTHA2830X150ATHA2830X150A2022-05-31
05037881027067Thoraflex™ HybridTHA3038X150ATHA3038X150A2022-05-31
05037881027074Thoraflex™ HybridTHA3040X150ATHA3040X150A2022-05-31
05037881031712Thoraflex™ HybridTHP2224X100BTHP2224X100B2025-09-04
05037881031729Thoraflex™ HybridTHP2426X100BTHP2426X100B2025-09-04
05037881031736Thoraflex™ HybridTHP2628X100BTHP2628X100B2025-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00803622104091Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104107Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104114Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104121Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104138Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104145Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104152Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104169Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622105692Venous cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104176Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104183Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104190Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104206Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104213Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104220Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104237Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104244Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104251Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104268Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104275Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104282Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104299Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104305Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104312Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104329Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104336Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104343Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104350Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104367Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104374Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17