dolphin Inflation Device

  • Model / Serial
    Lot Numbers: 15075668, 15075924, 15115426, 15125175, 16025324, 16035493, 16055261.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including PR and to the states of : LA, TN, CA, SC, OR, WA, OK, NV, HI, OH, TX.
  • Product Description
    Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. || DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). || The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. || Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. || All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

15 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number 15125173
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to MD, NY, and IL
  • Product Description
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, || Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
  • Manufacturer
  • Model / Serial
  • Product Description
    Injections / Infusions / Transfusions / Dialysis - catheters
  • Manufacturer
10 more