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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mechanical thrombolysis catheter
Definition To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
Product CodeQEY
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BTG INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
EKOS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THROMBOLEX, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Oct-28-2022
2 Boston Scientific Corporation II Aug-01-2022
3 Merit Medical Systems, Inc. II Jan-02-2024
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