EVOQUE

Primary DI
00690103217445
Brand
EVOQUE
Company
Edwards Lifesciences LLC
Model
9850EV44US
Catalog number
9850EV44US
Device description
EDWARDS EVOQUE VALVE, 44MM
Published
2024-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPWProsthesis, Tricuspid Valve, Percutaneously Delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPWPercutaneously Delivered Prostheses And Tricuspid ValvesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230013000Edwards EVOQUE Tricuspid Valve Replacement SystemEdwards Lifesciences, LLC2024-02-01NPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103217445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103217445006901032174456901032174450690103217445

GMDN Terms#

Term, Definition table
TermDefinition
Tricuspid transcatheter heart valve bioprosthesisAn implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant tricuspid heart valve, or previously-implanted tricuspid heart valve prosthesis, and which is implanted using a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter44Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling 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
Serial number
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
00690103219562Edwards EVOQUE Loading SystemEdwards Lifesciences LLCNPW2025-07-09
00690103217773Edwards EVOQUE Loading SystemEdwards Lifesciences LLCNPW2024-10-03
00690103219074Edwards EVOQUE ValveEdwards Lifesciences LLCNPW2024-10-03
00690103217490EVOQUEEdwards Lifesciences LLCNPW2024-02-07
00690103217506EVOQUEEdwards Lifesciences LLCNPW2024-02-07
00690103217520EVOQUEEdwards Lifesciences LLCNPW2024-02-07
00690103217452EVOQUEEdwards Lifesciences LLCNPW2024-02-06
00690103217469EVOQUEEdwards Lifesciences LLCNPW2024-02-06