Extractor, Vein

Device Code: 5768

Product Code(s): NJZ

Definition: The Device Is A Vein Extractor That Is Pushed Through The Leg Around The Vein To Effect Saphenous Vein Harvesting. It Is Like A Long Apple Corer, But Instead Of Taking Out The Apple Core You Are Taking Our Someone's Saphenous Vein.

Device Classification Information

Device Type ID5768
Device NameExtractor, Vein
Regulation DescriptionManual Surgical Instrument For General Use.
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 Two - Surgical (GSDB2)
Submission Type510(K) Exempt
CFR Regulation Number878.4800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNJZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5768
DeviceExtractor, Vein
Product CodeNJZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Surgical Instrument For General Use.
CFR Regulation Number878.4800 [🔎]
TPLC Last Update: 2019-04-02 21:12:12

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