FDA-Device2015-07-01Class II
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Volcano Corporation
Hazard
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Sold states
US Nationwide Distribution and one account in Canada.
Affected count
162 total devices (included both products)
Manufactured in
2870 Kilgore Rd, Rancho Cordova, CA, United States
Products
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1844-2015Don't want to check this manually?
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