CLIP DELIVERY SYSTEM, MITRACLIP US
MITRACLIP - CDS0201
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
- 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: NKM
Device Name: Mitral Valve Repair Devices
Device Class: 3
Physical State: N/A
Definition: To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.
Submission Type ID: 2
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: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device Identifiers
Device Id: 08717648195914
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
