Datascope Corp

  • Manufacturer Address
    Datascope Corp, 15 Law Drive, Fairfield NJ 07004-3206
  • Source
    USFDA
  • 1 Event

One device in the database

  • Model / Serial
    REF or Order #0684-00-0195-02; P/N #0684-00-0438; Lot #BRV; Exp. Date 03/03/05.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.
  • Product Description
    10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.

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