Bridge Occlusion Balloon

  • Model / Serial
    FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
  • Product Description
    Bridge Occlusion Balloon. Model: 590-001 || Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Spectranetics Corporation, 9965 Federal Drive, Colorado Springs CO 80921-3617
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

8 devices with a similar name

Learn more about the data here

  • Model / Serial
    590-001 | FMN16F22A, FMN16H23A
  • Product Description
    MD: Intravascular occluding catheter; Atherectomy laser system beam guide-catheter, coronary and peripheral
  • Manufacturer
3 more