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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
Regulation Description Embolectomy 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
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIQUET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
THROMBOLEX, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2023 1 1
2024 1 1
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Leak/Splash 2 2
Break 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Dysphasia 1 1
Superficial (First Degree) Burn 1 1
Arrhythmia 1 1
Abrasion 1 1
Intracranial Hemorrhage 1 1
Asystole 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 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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