Extractor, Vein
The Vein Extractor is a surgical instrument used during saphenous vein harvesting procedures, inserted through the leg around the vein to extract it for use as a vascular graft (e.g., in coronary artery bypass surgery). It is classified as FDA Class 1 (General Controls), under product code NJZ and regulation 21 CFR 878.4800 in the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- NJZ
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.