- Physicians Office Resource

STEERABLE GUIDE CATHETER, MITRACLIP US
MITRACLIP - SGC0101

Device Description

A 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.

Environmental Conditions

Special Storage Condition, Specify

Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DRA

Device Name: Catheter, Steerable

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1280

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 08717648195921

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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