FDA.reportPublic FDA data

EVOQUE

Primary DI
00690103217506
Brand
EVOQUE
Company
Edwards Lifesciences LLC
Model
9850DKUS
Catalog number
9850DKUS
Device description
Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators)
Published
2024-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00690103217506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103217506006901032175066901032175060690103217506

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
134139174
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
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
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
00690103192049ThruPort Systems Embol-X Introducer SheathEXISEXIS2016-08-31

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
00690103217520EVOQUEEdwards Lifesciences LLCNPW2024-02-07
00690103217445EVOQUEEdwards Lifesciences LLCNPW2024-02-06
00690103217452EVOQUEEdwards Lifesciences LLCNPW2024-02-06
00690103217469EVOQUEEdwards Lifesciences LLCNPW2024-02-06