9F Pruitt F3 Outlying Carotid Shunt with Tport

  • Model / Serial
    Lot Number: PFT2209
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.
  • Product Description
    LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port || The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Lemaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Source
    USFDA