- Physicians Office Resource

MitraClip G4 Clip Delivery System NTW
MITRACLIP - CDS0701-NTW

Device Description

An implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included.

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: 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: 08717648230967

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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