Devices

Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners.

  • Modèle / numéro de série
    Pre-Market Notification Number: N/A, Class I Exempt Device Device Listing No. 0043888, 0033972  ACROBAT V Off Pump Vacuum Stabilizer OM-9100S  25038623, 25039921, 25040646, 25041091, 25042446, 25042522  ACROBAT SUV Off Pump Vacuum Stabilizer OM-9000S  25035819, 25037049, 25037461, 25037587, 25037871, 25037986, 25038109, 25038366, 25038500, 2503853, 25038947, 25039317, 25039450, 25039769, 25040040, 25040124, 25040530, 25040864, 25040945, 25041319, 25041599, 25041689, 25041954, 25042126, 25042237  ACROBAT Off Pump Mechanical Stabilizer OM-6000S  25040360, 25042190
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Description du dispositif
    ACROBAT Stabilizers- || ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) || Product Usage: || The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
  • Manufacturer
    Maquet Cardiovascular, LLC
  • 1 Event

Fabricant

Maquet Cardiovascular, LLC
  • Adresse du fabricant
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA

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Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners.
  • Modèle / numéro de série
    Pre-Market Notification Number: N/A, Class I Exempt Device Device Listing No. 0043888, 0033972  AXIUS XPOSE 3 Off Pump Positioner XP-3000   25037165, 25037244, 25038989, 25040320, 25040776   XPOSE 4 Off Pump Positioner XP-4000   25037059, 25037396, 25037447, 25037894, 25038001, 25038376, 25038550, 25038874, 25039267, 25039158, 25039455, 25039915, 25040060, 25040465, 25040617, 25040866, 25041058, 25041248, 25041714, 25041606, 25042076, 25042550
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Description du dispositif
    XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. || Product Usage: || The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
  • Manufacturer
    Maquet Cardiovascular, LLC