Devices

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

  • Modelo / Serial
    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
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide
  • Descripción del producto
    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

Fabricante

Maquet Cardiovascular, LLC
  • Dirección del fabricante
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA

Dispositivo con un nombre similar

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Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners.
  • Modelo / Serial
    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
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide
  • Descripción del producto
    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