Devices

Device Recall Cholangioscopy Access Balloon

  • Modèle / numéro de série
    Reorder number: DPOC-15, Lot numbers: W2834630, W2835211, W2871208, W2871209, W2889215, W2889216, W2889217, W2889218, W2899398, W2899399, W2902200, W2902201, W2907649, W2907650, W2910395, W2910396, W2914136, W2914137, W2916501, W2916502, W2918945, W2918946, W2920993, W2920994, W2926799, W2926800, W2928562, W2928563, W2930338, W2930882, W2932781, W2932858, W2935202, W2935243 and WR2926438.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..
  • Description du dispositif
    DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 || This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
  • Manufacturer
    Cook Endoscopy
  • 1 Event

Fabricant

Cook Endoscopy
  • Adresse du fabricant
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA

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Device Recall Cholangioscopy Access Balloon
  • Modèle / numéro de série
    DPOC-20, Lot number: W2834631
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..
  • Description du dispositif
    DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105 || This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
  • Manufacturer
    Cook Endoscopy