FDA.reportPublic FDA data

MitraClip™ and TriClip™

Primary DI
05415067035950
Brand
MitraClip™ and TriClip™
Company
ST. JUDE MEDICAL, INC.
Model
PLT07
Catalog number
PLT07
Device description
Accessories Support Plate
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QWACardiovascular Delivery Catheter System Positioning and Stabilization Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWACardiovascular Delivery Catheter System Positioning And Stabilization DeviceCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067035950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067035950054150670359505415067035950

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular implant implantation tool baseA plate-like device intended to function as a sturdy support (base) for the holder/implantation tool of a cardiovascular implant (e.g., biologic-polymer aorta graft, heart valve bioprosthesis). It may be made of plastic and/or metallic material and includes means (e.g., slots, posts) for temporary attachment of the holder/implantation tool to enable vertical positioning and/or loading during the procedure. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067032195EnSite™ENSITE-FF-01ENSITE-FF-012021-01-06
05415067032201EnSite™ENSITE-R-FF-01ENSITE-R-FF-012021-01-06
05415067024732EnSite Precision™H702473H7024732020-07-22
05415067024695EnSite Precision™H702469H7024692016-12-20
05415067024701EnSite Precision™H702470H7024702016-12-20
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859244007081CouplerEBR Systems, Inc.QWA2026-07-08
05415067035967MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067035974MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067046529MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
07540162100338Globe® PlatformKardium IncQWA2025-09-15
07540162100352Globe® Catheter Cable SupportKardium IncQWA2025-09-15
07540162100345Globe® PlatformKardium IncQWA2025-09-15
07540162100369Globe® Catheter Cable SupportKardium IncQWA2025-09-15
00690103219494Edwards Reusable Rail ExtensionEdwards Lifesciences LLCQWA2025-07-09
00690103219500Edwards Reusable RailEdwards Lifesciences LLCQWA2025-07-09
00690103219579Edwards EVOQUE Stabilizer Edwards Lifesciences LLCQWA2025-07-09
00690103220001Edwards rail trayEdwards Lifesciences LLCQWA2025-07-09
00690103217278EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103217292EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103218015EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103217483EVOQUEEdwards Lifesciences LLCQWA2024-02-07
00690103217513EVOQUEEdwards Lifesciences LLCQWA2024-02-07
00690103217476EVOQUEEdwards Lifesciences LLCQWA2024-02-06
00690103217285EdwardsEdwards Lifesciences LLCQWA2023-07-10
00690103217308EdwardsEdwards Lifesciences LLCQWA2023-07-10
00690103218008EdwardsEdwards Lifesciences LLCQWA2023-07-10