FDA.reportPublic FDA data

Rigid Saddle Ring

Primary DI
05415067044655
Brand
Rigid Saddle Ring
Company
ST. JUDE MEDICAL, INC.
Model
RSAR-26
Catalog number
RSAR-26
Device description
Rigid Saddle Ring
Published
2024-02-02
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
KRHRING, ANNULOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRHRing, AnnuloplastyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042734000SJM RIGID SADDLE RING MODEL RSAR-(SIZE)St. Jude Medical, Inc.2004-12-17KRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734009423PreviousGS10
05415067044655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734009423054147340094235414734009423
05415067044655054150670446555415067044655

GMDN Terms#

Term, Definition table
TermDefinition
Mitral/tricuspid annuloplasty ring, open-surgeryA circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter26Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734008242Fast-Cath™4061044061042015-03-20
05414734008266Fast-Cath™4061204061202015-03-20
05414734008280Fast-Cath™4061284061282015-03-20
05414734008303Fast-Cath™4061404061402015-03-12
05414734008327Fast-Cath™4061624061622015-02-28
05414734008341Maximum™4062504062502015-04-11
05414734008365Maximum™4062514062512015-04-11
05414734008389Maximum™4062524062522015-04-11
05414734008402Maximum™4062534062532015-04-11
05414734008426Maximum™4062554062552015-04-10
05414734008488Maximum™4062594062592015-04-11
05414734008501Maximum™4063474063472015-04-11
05414734008525Maximum™4063594063592015-04-11
05414734008549Maximum™4063694063692015-04-10
05414734008563Fast-Cath™4065404065402015-02-28
05414734008587Fast-Cath™4065424065422015-02-28
05414734008600Fast-Cath™4065444065442015-02-28
05414734008648Maximum™4066534066532015-04-10
05414734008662Maximum™4066634066632015-04-10
05414734008808ULTIMUM™4078314078312015-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08022057015952Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057015969Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057015976Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057015983Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057015990Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016003Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016010Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016027Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016034Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016041Memo 4D CurveCORCYM SRLKRH2026-07-04
00763000659301SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659318SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659325SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659332SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659349SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659356SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659363SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659370SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659387SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659394SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659400SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659417SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659424SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659431SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659448SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659455SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659462SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659509Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659516Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659523Tri-Ad™MEDTRONIC, INC.KRH2026-02-02