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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
Regulation Description Ear, nose, and throat manual surgical instrument.
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

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 1 1
No Known Impact Or Consequence To Patient 1 1

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