FDA.report

Thoraflex™ Hybrid

Primary DI
05037881031774
Brand
Thoraflex™ Hybrid
Company
VASCUTEK LTD
Model
THP3036X100B
Catalog number
THP3036X100B
Device description
Thoraflex Hybrid Plexus
Published
2025-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
QSKHybrid stent graft, thoracic aortic lesion treatment

Product Code Classifications

CodeDeviceSpecialtyClass
QSKHybrid Stent Graft, Thoracic Aortic Lesion TreatmentUnknown3

Premarket Submissions

SubmissionSupplement
P210006000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P210006000Thoraflex™ HybridVascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Date Received02/25/2021 Decision Date04/19/2022 Product Code QSK  Advisory Committee Cardiovascular Clinical TrialsNCT02724072 Expedited Review Granted? No2022-04-19QSK 

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05037881031774PrimaryGS10

GMDN Terms

TermDefinition
Synthetic vascular graftAn 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.

Device Sizes

TypeValueUnit
Stent Diameter36Millimeter
Stent Length100Millimeter

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+44441418125555tmccustomer.admin@terumomedical.com

Regulatory Flags

DUNS number
229053087
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05037881031712Thoraflex™ HybridTHP2224X100BTHP2224X100B2025-09-04
05037881031729Thoraflex™ HybridTHP2426X100BTHP2426X100B2025-09-04
05037881031736Thoraflex™ HybridTHP2628X100BTHP2628X100B2025-09-04
05037881031743Thoraflex™ HybridTHP2830X100BTHP2830X100B2025-09-04
05037881031750Thoraflex™ HybridTHP3032X100BTHP3032X100B2025-09-04
05037881031767Thoraflex™ HybridTHP3034X100BTHP3034X100B2025-09-04
05037881031781Thoraflex™ HybridTHP3038X100BTHP3038X100B2025-09-04
05037881031798Thoraflex™ HybridTHP3040X100BTHP3040X100B2025-09-04
05037881031804Thoraflex™ HybridTHP3240X100BTHP3240X100B2025-09-04
05037881031811Thoraflex™ HybridTHP2224X150BTHP2224X150B2025-09-04
05037881031828Thoraflex™ HybridTHP2426X150BTHP2426X150B2025-09-04
05037881031835Thoraflex™ HybridTHP2628X150BTHP2628X150B2025-09-04
05037881031842Thoraflex™ HybridTHP2830X150BTHP2830X150B2025-09-04
05037881031859Thoraflex™ HybridTHP3032X150BTHP3032X150B2025-09-04
05037881031866Thoraflex™ HybridTHP3034X150BTHP3034X150B2025-09-04
05037881031873Thoraflex™ HybridTHP3036X150BTHP3036X150B2025-09-04
05037881031880Thoraflex™ HybridTHP3038X150BTHP3038X150B2025-09-04
05037881031897Thoraflex™ HybridTHP3040X150BTHP3040X150B2025-09-04
05037881031903Thoraflex™ HybridTHP3240X150BTHP3240X150B2025-09-04
05037881031910Thoraflex™ HybridTHA2224X100BTHA2224X100B2025-09-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05037881031712Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031729Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031736Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031743Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031750Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031767Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031781Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031798Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031804Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031811Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031828Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031835Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031842Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031859Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031866Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031873Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031880Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031897Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031903Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031910Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031927Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031934Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031941Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031958Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031965Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031972Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031989Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031996Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881032009Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881032016Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04