FDA.reportPublic FDA data

EDWARDS CERTITUDE INTRODUCER SHEATH SET

Primary DI
00690103194180
Brand
EDWARDS CERTITUDE INTRODUCER SHEATH SET
Company
Edwards Lifesciences LLC
Model
9600IS21
Catalog number
9600IS21A
Device description
EDWARDS CERTITUDE INTRODUCER SHEATH SET
Published
2017-01-09
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
NPTAortic valve, prosthesis, percutaneously delivered
NPUProsthesis, Mitral Valve, Percutaneously Delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPTAortic Valve, Prosthesis, Percutaneously DeliveredUnknown3
NPUProsthesis, Mitral Valve, Percutaneously DeliveredUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140031024
P140031028
P140031074
P140031107
P140031112

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140031024SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2015-06-17NPT
P140031028SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2015-06-17NPT
P140031074SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2015-06-17NPT
P140031107SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2015-06-17NPT
P140031112SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2015-06-17NPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103194180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103194180006901031941806901031941800690103194180

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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 typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00COOL, DRY PLACE.

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
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
00850000898103Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898110Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898127Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898134Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898141Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898158Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898165Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898172Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898189Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898196Trilogy Introducer SheathJenavalve Technology, Inc.NPT2026-03-25
00850000898202Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898219Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898226Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00690103219753SAPIEN M3 Transcatheter Heart ValveEdwards Lifesciences LLCNPU2026-01-30
00690103219760SAPIEN M3 Dock Steerable CatheterEdwards Lifesciences LLCNPU2026-01-30
00690103219777Edwards Commander M Delivery SystemEdwards Lifesciences LLCNPU2026-01-30
00690103219784Edwards 23F Guide SheathEdwards Lifesciences LLCNPU2026-01-30
00690103219791SAPIEN M3 CrimperEdwards Lifesciences LLCNPU2026-01-30
05415067032027Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032096Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032447Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032454Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032461Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032478Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032485Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032492Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032508Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032515Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032522Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032539Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29