FDA.reportPublic FDA data

MitraClip™

Primary DI
05415067050779
Brand
MitraClip™
Company
ST. JUDE MEDICAL, INC.
Model
CDS0801-XTW
Catalog number
CDS0801-XTW
Device description
G5 Delivery System
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKMMitral valve repair devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKMMitral Valve Repair DevicesUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067050779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067050779054150670507795415067050779

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve clipAn implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth6Millimeter
Length12Millimeter
Width22Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067033307Amplatzer™ Talisman™9-PFO-18189-PFO-18182021-09-29
05415067033314Amplatzer™ Talisman™9-PFO-25189-PFO-25182021-09-29
05415067033321Amplatzer™ Talisman™9-PFO-30259-PFO-30252021-09-29
05415067033345Amplatzer™ Talisman™9-PFO-35259-PFO-35252021-09-29
00811806011103Amplatzer™9-PDA-0039-PDA-0032014-09-08
00811806011110Amplatzer™9-PDA-0049-PDA-0042014-09-08
00811806011127Amplatzer™9-PDA-0059-PDA-0052014-09-08
00811806011134Amplatzer™9-PDA-0069-PDA-0062014-09-08
00811806011141Amplatzer™9-PDA-0079-PDA-0072014-09-08
00811806011172Amplatzer™9-PDA2-03-049-PDA2-03-042014-09-08
00811806011189Amplatzer™9-PDA2-03-069-PDA2-03-062014-09-19
00811806011202Amplatzer™9-PDA2-04-049-PDA2-04-042014-09-15
00811806011219Amplatzer™9-PDA2-04-069-PDA2-04-062014-09-15
00811806011233Amplatzer™9-PDA2-05-049-PDA2-05-042014-09-15
00811806011240Amplatzer™9-PDA2-05-069-PDA2-05-062014-09-15
00811806011257Amplatzer™9-PDA2-06-049-PDA2-06-042014-09-15
00811806011264Amplatzer™9-PDA2-06-069-PDA2-06-062014-09-15
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067050717MitraClip™ST. JUDE MEDICAL, INC.NKM2025-12-11
05415067050748MitraClip™ST. JUDE MEDICAL, INC.NKM2025-12-11
05415067050762MitraClip™ST. JUDE MEDICAL, INC.NKM2025-12-11
05415067037367MitraClip™ST. JUDE MEDICAL, INC.NKM2022-09-20
05415067037381MitraClip™ST. JUDE MEDICAL, INC.NKM2022-09-20
05415067037404MitraClip™ST. JUDE MEDICAL, INC.NKM2022-09-20
05415067037435MitraClip™ST. JUDE MEDICAL, INC.NKM2022-09-20
00690103216943PASCALEdwards Lifesciences LLCNKM2022-09-19
00690103216950PASCALEdwards Lifesciences LLCNKM2022-09-19
00690103216967PASCAL PRECISIONEdwards Lifesciences LLCNKM2022-09-19
00690103216974PASCALEdwards Lifesciences LLCNKM2022-09-19
00690103216981PASCALEdwards Lifesciences LLCNKM2022-09-19
08717648230943MITRACLIPABBOTT VASCULAR INC.NKM2019-11-11
08717648230967MITRACLIPABBOTT VASCULAR INC.NKM2019-11-11
08717648230981MITRACLIPABBOTT VASCULAR INC.NKM2019-11-11
08717648231001MITRACLIPABBOTT VASCULAR INC.NKM2019-11-11
08717648226342MITRACLIPABBOTT VASCULAR INC.NKM2018-07-09
08717648226366MITRACLIPABBOTT VASCULAR INC.NKM2018-07-09
08717648216800MITRACLIPABBOTT VASCULAR INC.NKM2016-09-22
08717648195914MITRACLIPABBOTT VASCULARNKM2014-11-21