Manufacturers

Datascope Collagen Products Division

  • Manufacturer Address
    Datascope Collagen Products Division, 1300 MacArthur Blvd., Mahwah NJ 07430-0605
  • Source
    USFDA
  • 1 Event

One device in the database

Device Recall VasoSeal ES
  • Model / Serial
    Lot No. 0605374, Exp. Date May 2005.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The device was distributed throughout the US to 101 direct accounts. There was one distributor. There was one government account.
  • Product Description
    VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. The device is indicated for use in sealing the femoral arterial puncture site.