Device Recall POWERSAIL

  • Model / Serial
    Lot 8053061(exp 04-2010)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.
  • Product Description
    POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) || Part #1005524-08
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot 7101051 (exp 09-2009)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.
  • Product Description
    POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) || Part #1005524-18
  • Manufacturer
  • Model / Serial
    Lot 7112051(exp 10-2009)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.
  • Product Description
    POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) || Part #1005726-08
  • Manufacturer
  • Model / Serial
    Lot 8012151(exp 12-2009)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.
  • Product Description
    POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) || Part #1005522-18
  • Manufacturer