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 Type ID | 5768 |
Device Name | Extractor, Vein |
Regulation Description | Manual Surgical Instrument For General Use. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 878.4800 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NJZ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5768 |
Device | Extractor, Vein |
Product Code | NJZ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Surgical Instrument For General Use. |
CFR Regulation Number | 878.4800 [🔎] |