Insufflator, Endoscopic Vessel Harvesting
The Insufflator, Endoscopic Vessel Harvesting (product code OSV) is a device that provides selected flow rates and pressures of CO2 gas to separate tissue planes during endoscopic vessel harvesting procedures, enabling isolation and ligation of the saphenous vein or radial artery for use in bypass grafting. It is used in minimally invasive cardiac and vascular surgery. As an FDA Class 2 device under regulation 884.1730, it requires 510(k) premarket clearance and falls within the Obstetrics/Gynecology specialty by regulation. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OSV
- Device Class
- FDA class 2
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.