FDA.reportPublic FDA data

EVOQUE

Primary DI
00690103217452
Brand
EVOQUE
Company
Edwards Lifesciences LLC
Model
9850EV48US
Catalog number
9850EV48US
Device description
EDWARDS EVOQUE VALVE, 48MM
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
00690103217452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103217452006901032174526901032174520690103217452

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 Diameter48Millimeter

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
00690103220636ESHEATH OPTIMA14000ES16A14000ES162025-10-09
00690103219784Edwards 23F Guide Sheath9880GS9880GSA2026-01-30
00690103219562Edwards EVOQUE Loading System9850LSB9850LSBUS2025-07-09
00690103219579Edwards EVOQUE Stabilizer9850SZUS9850SZUS2025-07-09
00690103220629ESHEATH OPTIMA INTRODUCER SET (14F)14000ES1414000ES142025-05-07
00690103217773Edwards EVOQUE Loading System9850LSAUS9850LSAUS2024-10-03
00690103217483EVOQUE9850PTUS9850PTUS2024-02-07
00690103217490EVOQUE9850LSUS9850LSUS2024-02-07
00690103217506EVOQUE9850DKUS9850DKUS2024-02-07
00690103217513EVOQUE9850SBUS9850SBUS2024-02-07
00690103217476EVOQUE9850BAUS9850BAUS2024-02-06
00690103215465Edwards eSheath+ Introducer set914ESP914ESPA2021-10-06
00690103215472Edwards eSheath+ Introducer set916ESP916ESPA2021-10-06
00690103182262EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T262015-09-24
00690103182279EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T282015-09-24
00690103182286EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T302015-09-24
00690103182293EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T322015-09-24
00690103182309EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T342015-09-24
00690103182316EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T362015-09-24
00690103190816Thruport Systems Introducer Sheath KitIS19AIS19A2016-08-31

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
00690103217445EVOQUEEdwards Lifesciences LLCNPW2024-02-06
00690103217469EVOQUEEdwards Lifesciences LLCNPW2024-02-06