FDA.reportPublic FDA data

Heart valve clip

Definition
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.
GUDID devices
21
Last updated
2026-10-04 01:48:28

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00690103221664PASCAL Ace with Capture Clarity Valve Repair SystemEdwards Lifesciences LLC30000ACEMR2026-09-24
00690103222388PASCAL PrecisionEdwards Lifesciences LLC20000GS2026-09-24
05415067050717MitraClip™ST. JUDE MEDICAL, INC.CDS0801-NT2025-12-11
05415067050731TriClip™ST. JUDE MEDICAL, INC.TCDS0801-XTW2025-12-11
05415067050748MitraClip™ST. JUDE MEDICAL, INC.CDS0801-NTW2025-12-11
05415067050762MitraClip™ST. JUDE MEDICAL, INC.CDS0801-XT2025-12-11
05415067050779MitraClip™ST. JUDE MEDICAL, INC.CDS0801-XTW2025-12-11
05415067050816TriClip™ST. JUDE MEDICAL, INC.TCDS0801-NTW2025-12-11
05415067050847TriClip™ST. JUDE MEDICAL, INC.TCDS0801-XT2025-12-11
05415067050885TriClip™ST. JUDE MEDICAL, INC.TCDS0801-NT2025-12-11
05415067047700TriClip™ST. JUDE MEDICAL, INC.TCDS0301-NT2024-04-12
05415067047724TriClip™ST. JUDE MEDICAL, INC.TCDS0301-NTW2024-04-12
05415067047731TriClip™ST. JUDE MEDICAL, INC.TCDS0301-XT2024-04-12
05415067047755TriClip™ST. JUDE MEDICAL, INC.TCDS0301-XTW2024-04-12
05415067037367MitraClip™ST. JUDE MEDICAL, INC.CDS0706-NT2022-09-20
05415067037381MitraClip™ST. JUDE MEDICAL, INC.CDS0706-XTW2022-09-20
05415067037404MitraClip™ST. JUDE MEDICAL, INC.CDS0706-XT2022-09-20
05415067037435MitraClip™ST. JUDE MEDICAL, INC.CDS0706-NTW2022-09-20
00690103216943PASCALEdwards Lifesciences LLC20000IS2022-09-19
00690103216950PASCALEdwards Lifesciences LLC20000ISM2022-09-19
00690103216967PASCAL PRECISIONEdwards Lifesciences LLC20000GSA2022-09-19