FDA.reportPublic FDA data

MitraClip™ and TriClip™

Primary DI
05415067035967
Brand
MitraClip™ and TriClip™
Company
ST. JUDE MEDICAL, INC.
Model
SZR07
Catalog number
SZR07
Device description
Accessories Stabilizer
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
05415067035967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067035967054150670359675415067035967

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067053039Current™PFA-AMP-RETURN-CBLPFA-AMP-RETURN-CBL2026-08-03
05415067055002Current™PFA-TSQ-CBLPFA-TSQ-CBL2026-08-03
05415067055583Current™PFA-GEN-OVERLAY-FPFA-GEN-OVERLAY-F2026-08-03
05415067055897Current™PFA-GEN-V110PFA-GEN-V1102026-08-03
00811806011295Amplatzer™9-PFO-0309-PFO-0302026-07-31
05415067045447Epic™EMAX-21EMAX-212023-08-01
05415067045454Epic™EMAX-25EMAX-252023-08-01
05415067045461Epic™EMAX-19EMAX-192023-08-01
05415067045478Epic™EMAX-23EMAX-232023-08-01
05415067033017Epic™E200-21AE200-21A2021-12-09
05415067033024Epic™E200-23AE200-23A2021-12-09
05415067033031Epic™E200-25AE200-25A2021-12-09
05415067033048Epic™E200-25ME200-25M2021-12-09
05415067033055Epic™E200-27AE200-27A2021-12-09
05415067033062Epic™E200-27ME200-27M2021-12-09
05415067033079Epic™E200-29AE200-29A2021-12-09
05415067033086Epic™E200-29ME200-29M2021-12-09
05415067033093Epic™E200-31ME200-31M2021-12-09
05415067033109Epic™E200-33ME200-33M2021-12-09
05415067033116Epic™ESP200-19ESP200-192021-12-09

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
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