FDA.reportPublic FDA data

AMDS Hybrid Prosthesis ("AMDS")

Primary DI
00877234001420
Brand
AMDS Hybrid Prosthesis ("AMDS")
Company
Artivion, Inc.
Model
K060004
Catalog number
AMDS40c
Device description
40mm (Classic) Straight Stent (28mm collar)
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSKHybrid Stent Graft, Thoracic Aortic Lesion Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSKHybrid Stent Graft, Thoracic Aortic Lesion TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250055000AMDS Hybrid ProsthesisArtivion, Inc.2026-06-26QSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877234001420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877234001420008772340014208772340014200877234001420

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal aortic stentA non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1(888) 427-9654customerservice.us@artivion.com

Regulatory Flags#

DUNS number
119253177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877234001437AMDS Hybrid Prosthesis ("AMDS")K060005AMDS4030c2026-08-07
00877234001444AMDS Hybrid Prosthesis ("AMDS")K060006AMDS552026-08-07
00877234001451AMDS Hybrid Prosthesis ("AMDS")K060007AMDS55402026-08-07
00877234001635PhotoFix Decellularized Bovine PericardiumPFP6X8PFP6X82026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumPFP0.8X8PFP0.8X82026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumPFP1X6PFP1X62026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumPFP4X4PFP4X42026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumPFP2X9PFP2X92026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumPFP1X10PFP1X102026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumPFP1X14PFP1X142026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumPFP8X14PFP8X142026-05-29
00877234000096CardioGenesisNS2000LSR-SG2100S2016-12-12
00877234000447CryoValve® SG Pulmonary Human Heart Valve SGPV00SGPV002015-09-11
00877234000454CryoValve® SG Pulmonary Human Heart Valve SGPV10SGPV102015-09-11
00877234000102CardioGenesisHP-SG3HP-SG32016-12-12
00877234001192"AMDS Hybrid Prosthesis (""AMDS"")"K039420AMDS40 2025-02-05
00877234001208"AMDS Hybrid Prosthesis (""AMDS"")"K039421AMDS4030 2025-02-05
00877234001215"AMDS Hybrid Prosthesis (""AMDS"")"K039422AMDS55 2025-02-05
00877234001222"AMDS Hybrid Prosthesis (""AMDS"")"K039423AMDS55402025-02-05
00877234001321"AMDS Hybrid Prosthesis (""AMDS"")"K038896AMDS4030c 2025-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00877234001437AMDS Hybrid Prosthesis ("AMDS")Artivion, Inc.QSK2026-08-07
00877234001444AMDS Hybrid Prosthesis ("AMDS")Artivion, Inc.QSK2026-08-07
00877234001451AMDS Hybrid Prosthesis ("AMDS")Artivion, Inc.QSK2026-08-07
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
05037881031774Thoraflex™ 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