FDA.reportPublic FDA data

Attune™

Primary DI
05414734029964
Brand
Attune™
Company
ST. JUDE MEDICAL, INC.
Model
AFR-27
Catalog number
AFR-27
Device description
Flexible Adjustable Annuloplasty Ring
Published
2015-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K092876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092876000SJM ATTUNE ANNULOPLASTY RINGSt Jude Medical2009-10-16KRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734029964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734029964054147340299645414734029964

GMDN Terms#

Term, Definition table
TermDefinition
Mitral/tricuspid annuloplasty ringA sterile circular band intended to be implanted in the heart for the reconstruction and/or remodelling of insufficient and/or stenotic mitral and tricuspid valves. It is typically mounted on a disposable holder assembly to enable it to maintain its shape and aid in its implantation with sutures. 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 Diameter27Millimeter

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
05415067054463Ampere™AMP-TFDM-01AMP-TFDM-012026-08-19
05415067054661TactiSys™TSQ-V1.8-TFDM-01TSQ-V1.8-TFDM-012026-08-19
05415067055651EnSite™ENSITE-D-FOCAL-01ENSITE-D-FOCAL-012026-08-19
05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
05415067055682EnSite™ENSITE-FOCAL-01ENSITE-FOCAL-012026-08-19
05415067050724TriClip™TSGC0801TSGC08012025-12-11
05415067050908MitraClip™SGC0801SGC08012025-12-11
05415067051844Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-LSI-1371-L2025-02-07
05415067051851Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-MSI-1371-M2025-02-07
05415067050182Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-SSI-1371-S2024-08-15
05415067047748TriClip™TSGC0201TSGC02012024-04-12
05415067038487Aveir™LSCD201LSCD2012023-08-15
05415067036384Aveir™LSCD111LSCD1112023-03-03
05415067041517CPS AIM™DS2N100-59DS2N100-592022-10-20
05415067041524CPS Aim™DS2N100-65DS2N100-652022-10-20
05415067041586CPS AIM™DS2N104-65DS2N104-652022-10-20
05415067041739CPS AIM™DS2N101-65DS2N101-652022-10-20
05415067041746CPS AIM™DS2N103-65DS2N103-652022-10-20
05415067041753CPS AIM™DS2N102-65DS2N102-652022-10-20

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