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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser-powered inferior vena cava filter retrieval catheter
Definition A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters.
Product CodeQRJ
Regulation Number 870.5125
Device Class 2


Premarket Reviews
ManufacturerDecision
SPECTRANETICS, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2022 3 3
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 3 3
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unintended Radiation Exposure 5 5
Great Vessel Perforation 1 1

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