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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, angioplasty, peripheral, transluminal, dual-balloon
Regulation Description Percutaneous catheter.
Definition Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
Product CodeNVM
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 4 4
2023 1 2
2024 4 4
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 6 6
Off-Label Use 2 2
Signal Artifact/Noise 1 1
Break 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Capture 1 2
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Disconnect 1 1
Therapy Delivered to Incorrect Body Area 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 13
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Numed Inc II May-13-2025
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