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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporary embolization assist device, peripheral
Definition A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
Product CodeQZU
Regulation Number 870.3325
Device Class 2


Premarket Reviews
ManufacturerDecision
RAPID MEDICAL LTD.
  GRANTED 1

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