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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device balloon, nasal airway
Definition The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.
Product CodeQGK
Regulation Number 874.4420
Device Class 1


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 1 1
2022 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Patient Device Interaction Problem 2 2
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Decreased Sensitivity 1 1
Stroke/CVA 1 1
Perforation 1 1
Hematoma 1 1
No Known Impact Or Consequence To Patient 1 1
Ecchymosis 1 1
Perforation of Vessels 1 1
Swelling/ Edema 1 1

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