FDA.reportPublic FDA data

HEART VALVE ACCESSORY

Primary DI
00690103019650
Brand
HEART VALVE ACCESSORY
Company
Edwards Lifesciences LLC
Model
1170
Catalog number
117021MM
Device description
OBTURATOR,AORTIC F/PRIMA 21MM F/USE W/2500PA VLV N/S
Published
2026-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTISizer, Heart-Valve, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTISizer, Heart-Valve, ProsthesisCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103019650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103019650006901030196506901030196500690103019650

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve annulus sizer, reusableA hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9837tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
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
00690103019810HEART VALVE ACCESSORY1175T1175T302026-04-06
00690103019827HEART VALVE ACCESSORY1175T1175T322026-04-06
00690103019834HEART VALVE ACCESSORY1175T1175T342026-04-06
00690103019841HEART VALVE ACCESSORY1175T1175T362026-04-06
00690103019858HEART VALVE ACCESSORY1175T1175T382026-04-06
00690103019889KONECT AVC SIZER 19MM1190119019MM2026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000990657Mosaic Neo™ S310MNHMEDTRONIC, INC.DTI2026-04-13
00763000990664Mosaic Neo™ S310MNSMEDTRONIC, INC.DTI2026-04-13
00690103019643HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019674HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019698HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019704HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019711HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019728HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019735HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019742HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019759HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019766HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019773HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019780HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019797HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019803HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019810HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019827HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019834HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019841HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019858HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019889KONECT AVC SIZER 19MMEdwards Lifesciences LLCDTI2026-04-06
00690103019896KONECT AVC SIZER 21MMEdwards Lifesciences LLCDTI2026-04-06
00690103019902KONECT AVC SIZER 23MMEdwards Lifesciences LLCDTI2026-04-06
00690103019919KONECT AVC SIZER 25MMEdwards Lifesciences LLCDTI2026-04-06
00690103019926KONECT AVC SIZER 27MMEdwards Lifesciences LLCDTI2026-04-06
00690103185683SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLCDTI2026-04-06
00690103185690SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLCDTI2026-04-06
00690103185706SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLCDTI2026-04-06
00690103185713SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLCDTI2026-04-06