Device Recall Volcano PV 0.035 Catheter

  • Model / Serial
    Product number 88901; lot number 50002518
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution and one account in Canada.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Manufacturer Parent Company (2017)
  • Source
    USFDA