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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reprocessed catheter introducer
Regulation Description Catheter introducer.
Definition Introduce various cardiovascular catheters into the heart and cardiovascular system
Product CodePNE
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K212165  Reprocessed Carto Vizigo Bi-Directional Guiding Sh ...
  2.  K230376  Reprocessed Agilis NxT Steerable Introducer
  3.  K232037  Reprocessed VersaCross Steerable Sheath; Reprocess ...

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 5 5
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 5 5
Leak/Splash 2 2
Break 1 1
Air/Gas in Device 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Insufficient Information 1 1

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