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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, vessel, surgical
Product CodeDWP
Regulation Number 870.4475
Device Class 2


Premarket Reviews
ManufacturerDecision
FEHLING SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEOMED MEDIZIN-TECHNIK GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 4 4
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Break 3 3
Detachment of Device or Device Component 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Injury 2 2
Vascular Dissection 1 1
Atherosclerosis 1 1
Erosion 1 1
Tissue Damage 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
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