Reprocessed Balloon Inflation Device

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • Product Description
    Balloon Inflation Device || Model #'s: || MED15-105 || MED15-106 and || SCI04527-01 || The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the ballon and to deflate the ballon.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • Manufacturer Parent Company (2017)
  • Source
    USFDA