Clip, Implantable, For Coronary Artery Bypass Graft (cabg)

Device Code: 5761

Product Code(s): NCA

Device Classification Information

Device Type ID5761
Device NameClip, Implantable, For Coronary Artery Bypass Graft (cabg)
Regulation DescriptionImplantable Clip.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.4300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNCA
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5761
DeviceClip, Implantable, For Coronary Artery Bypass Graft (cabg)
Product CodeNCA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImplantable Clip.
CFR Regulation Number878.4300 [🔎]
TPLC Last Update: 2019-04-02 21:12:06

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