Fibered Gdc-18 Vortx Shape Guglielmi Detachable Coil

• • Terminated Z-0504-2014 FDA Class II ·initiated 4 Nov 2013 ·on shared 510(k) K993418

  Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K993418 ↗

FDA Product Code

HCG

Device Class

Class II

Regulation

21 CFR Part 882.5950

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Matrix Detachable Coils

  Class II

  FDA 510(k) K012985 Active Cleared 31 Jan 2002

• Gdc Stretch Resistant Detachable Coil

  Class II

  FDA 510(k) K030475 Active Cleared 14 Mar 2003

• In-Time Retrieval Device

  Class II

  FDA 510(k) K014109 Active Cleared 12 Mar 2002

• Guglielmi Detachable Coil (Gdc)

  Class II

  FDA 510(k) K031049 Active Cleared 1 Aug 2003

• Gdc Ultrasoft Coil

  Class II

  FDA 510(k) K002181 Active Cleared 11 Aug 2000

• Gdc-10 Guglielmi Detachable Coil (Gdc) (3D Shape Gdc), Gdc-18 Guglielmi Detachable Coil (Gdc) (3D Shape Gdc)

  Class II

  FDA 510(k) K993417 Active Cleared 21 Jan 2000

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