FDA.reportPublic FDA data

MITRACLIP

Primary DI
08717648195921
Brand
MITRACLIP
Company
ABBOTT VASCULAR
Model
SGC0101
Catalog number
SGC0101
Device description
STEERABLE GUIDE CATHETER, MITRACLIP US
Published
2014-11-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRACATHETER, STEERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648195921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648195921087176481959218717648195921

GMDN Terms#

Term, Definition table
TermDefinition
Mitral valve tissue repair systemA system of devices intended for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation using transvenous/transseptal techniques. It consists of a sterile clip delivery system (CDS), implantable metal clips, steerable delivery and guide catheters with a dilator (acts a conduit), and other devices to be sterilized prior to use. The steerable guide and CDS are typically steered and actuated through the use of control knobs, levers and torque translation techniques and guided by echocardiographic and fluoroscopic imaging. The clip is positioned and the mitral valve leaflets are coapted to reduce mitral regurgitation (MR). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags#

DUNS number
849716605
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717648195914MITRACLIPCDS0201CDS02012014-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024672554AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672561AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672578AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672585AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672592AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672608AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672615AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672622AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672639AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672646AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672653AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672660AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672677AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672684AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672691AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672707AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672714AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672721AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672738AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672745AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672752AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672769AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672776AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672783AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672790AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672806AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672813AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672820AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672837AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672844AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06