FDA.reportPublic FDA data

MitraClip™ and TriClip™

Primary DI
05415067035974
Brand
MitraClip™ and TriClip™
Company
ST. JUDE MEDICAL, INC.
Model
LFT07
Catalog number
LFT07
Device description
Accessories Lift
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
05415067035974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067035974054150670359745415067035974

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
05415067030092Advisor™H702532H7025322019-09-23
05415067031471Advisor™H702520H7025202019-09-23
05415067017031WorkMate Claris™H701703H7017032017-04-06
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067026149N/AH702499H7024992016-12-08
05415067026163EnSite™H702498-TH702498-T2016-12-20
05415067026194EnSite™H702500H7025002016-12-08
05415067026200EnSite™H702500-TH702500-T2016-12-08
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08
05415067052780Epic™EELT-27MEELT-27M2026-07-08
05415067052797Epic™ESP300-25ESP300-252026-07-08
05415067052803Epic™ESP300-19ESP300-192026-07-08
05415067052810Epic™EELT-19AEELT-19A2026-07-08
05415067052827Epic™EELT-29MEELT-29M2026-07-08
05415067052834Epic™EELT-27AEELT-27A2026-07-08
05415067052858Epic™EELT-25AEELT-25A2026-07-08
05415067052865Epic™EELT-21AEELT-21A2026-07-08
05415067052872Epic™EELT-33MEELT-33M2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859244007081CouplerEBR Systems, Inc.QWA2026-07-08
05415067035950MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067035967MitraClip™ 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