Arrow

  • Modèle / numéro de série
    Product No. AP-06016. Lot Numbers: MF2092160, MF2092258, MF4031012, MF4041798, MF4063372, MF4073836, MF4105283, MF6015284, MF6026177.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide. The firm is NOT recalling from international accounts.
  • Description du dispositif
    Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile Port. 6 Fr. Introducer Kit. || Ref. Product No. AP-06016.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
  • Source
    USFDA

570 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    All units with Lot Numbers beginning with: MF311; MF312; MF401; MF402; MF403; MF404; MF405; MF406; MF407; MF408; MF409; MF410; MF411; MF412; MF501.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed nationwide to dealers, hospitals, sales representatives, and subsidiaries (distributors). The product was also distributed to Australia, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Japan, Netherlands, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom. There are no government accounts.
  • Description du dispositif
    The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit.
  • Manufacturer
  • Modèle / numéro de série
    MF5124329
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.
  • Description du dispositif
    Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
  • Manufacturer
  • Modèle / numéro de série
    item KKX053850.0 - models KA1230 (with safety) and KA1240, with production dates of September 2006 through December 2006. The tag on the sling will state the item number and have the year ''06'' hole-punched in the top line ''Y'', and either the month ''09'', ''10'', ''11'' or ''12'' hole-punched in the third line ''M''.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
  • Manufacturer
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