FDA.reportPublic FDA data

Duravess

Primary DI
00690103199048
Brand
Duravess
Company
Edwards Lifesciences LLC
Model
DP2X9
Catalog number
DP2X9
Device description
Bovine pericardial vascular patch
Published
2018-05-29
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
PSQIntracardiac Patch Or Pledget, Biologically Derived

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSQIntracardiac Patch Or Pledget, Biologically DerivedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172660000Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC2017-11-17PSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103199048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103199048006901031990486901031990480690103199048

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, animal-derivedA sterile implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
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
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00877234001635PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00850023375087CardiaMendHelios Cardio Inc.PSQ2023-07-07
00085412818313Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818375Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818405Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818429Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818443Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818597Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818610Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818658Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818672Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818696Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00850023375063CardiaMendHelios Cardio Inc.PSQ2022-12-13
00850023375070CardiaMendHelios Cardio Inc.PSQ2022-12-13
00085412818474Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818498Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818511Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818535Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818559Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818573Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818634Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00850023375001CardiaMendHelios Cardio Inc.PSQ2022-02-01
00850023375018CardiaMendHelios Cardio Inc.PSQ2022-02-01