Product Code: NJZ FDA class 1 21 CFR 878.4800

Extractor, Vein

General, Plastic Surgery

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.

510(k)s
0
FEI Numbers
11
Registration Numbers
11
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.