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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device septostomy catheter, reprocessed
Definition To create or enlarge an atrial septal defect in the heart.
Product CodeQLZ
Regulation Number 870.5175
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 1 1

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

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