FDA.reportPublic FDA data

"AMDS Hybrid Prosthesis (""AMDS"")"

Primary DI
00877234001338
Brand
"AMDS Hybrid Prosthesis (""AMDS"")"
Company
Artivion, Inc.
Model
K038895
Catalog number
AMDS40c
Device description
40mm (Classic) Straight Stent (28mm collar)
Published
2025-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
H230007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H230007000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877234001338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877234001338008772340013388772340013380877234001338

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length527Millimeter
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 Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
119253177
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877234001727Chord-X® Premeasured Loops, 24mm loop (3/8 circle)CXL-20-1838-24CXL-20-1838-242026-10-30
00877234001741Chord-X® Premeasured Loops, 20mm loop (3/8 circle)CXL-20-1838-20CXL-20-1838-202026-10-30
00877234001765Chord-X® Premeasured Loops, 16mm loop (3/8 circle)CXL-20-1838-16CXL-20-1838-162026-10-30
00877234001789Chord-X® Premeasured Loops, 12mm loop (3/8 circle)CXL-20-1838-12CXL-20-1838-122026-10-30
00877234001802Chord-X® Suture System, Adjustable (3/8 circle)CXL-20-1838-0CXL-20-1838-02026-10-30
00877234001826Chord-X® Premeasured Loops, 24mm loop (1/2 circle)CXL-20-1812-24CXL-20-1812-242026-10-30
00877234001840Chord-X® Premeasured Loops, 20mm loop (1/2 circle)CXL-20-1812-20CXL-20-1812-202026-10-30
00877234001864Chord-X® Premeasured Loops, 16mm loop (1/2 circle)CXL-20-1812-16CXL-20-1812-162026-10-30
00877234001888Chord-X® Premeasured Loops, 12mm loop (1/2 circle)CXL-20-1812-12CXL-20-1812-122026-10-30
00877234001901Chord-X® Suture System, Adjustable (1/2 circle)CXL-20-1812-0CXL-20-1812-02026-10-30
00877234001918Chord-X® Chordal SizerCXCSCXCS2026-10-30
00877234001420AMDS Hybrid Prosthesis ("AMDS")K060004AMDS40c2026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00877234001420AMDS Hybrid Prosthesis ("AMDS")Artivion, Inc.QSK2026-08-07
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