Devices

Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE

  • Model / Serial
    Lot Numbers: 0909900001, 0909900002, 0909900003, 0910300036, 0913900016, 0919400039, 0922300001, 09025100113, 0927200178, 0929900094, 0930700016.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada and Italy.
  • Product Description
    Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. || The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
  • Manufacturer
    Sorin Group USA, Inc.
  • 1 Event

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE
  • Model / Serial
    Lot numbers: 0910300035, 0911100013, 0911700032, 0912400207, 0913100044, 0921500031, 0923700087, 0924300023, 0925100112, 0925100116, 092700175, 0929400008, 0929900092, 0930700014.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada and Italy.
  • Product Description
    Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. || The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
  • Manufacturer
    Sorin Group USA, Inc.
Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE
  • Model / Serial
    Lot Num,bers: 0910500009, 0912400208, 0915300001, 0922900039, 0925100117, 0927200177, 0929900093.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada and Italy.
  • Product Description
    Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. || The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
  • Manufacturer
    Sorin Group USA, Inc.
Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE
  • Model / Serial
    Lot Numbers: 0910300012, 0910500010, 0915300002, 0925100118, 0927200179, 0929900095.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada and Italy.
  • Product Description
    Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. || The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
  • Manufacturer
    Sorin Group USA, Inc.
Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE
  • Model / Serial
    Lot Numbers: 0914600039, 0930700018.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada and Italy.
  • Product Description
    Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. || The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
  • Manufacturer
    Sorin Group USA, Inc.
Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE
  • Model / Serial
    Lot Numbers: 0916600195, 0925100114, 0922900040, 0927200176, 0929400009.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada and Italy.
  • Product Description
    Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. || The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
  • Manufacturer
    Sorin Group USA, Inc.
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