Relieva Tract Balloon Dilation System
FDA 510(k) K183090 · Acclarent, Inc.
510(k) numberK183090
Submission
- Device name
- Relieva Tract Balloon Dilation System
- Applicant
- Acclarent, Inc.
Irvin, CA, US - Received
- November 6, 2018
- Decision date
- April 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QGK – Balloon, Nasal Airway
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
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.
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Questions and answers
When was Relieva Tract Balloon Dilation System cleared by the FDA?
Relieva Tract Balloon Dilation System (K183090) received a 510(k) decision of Substantially Equivalent on April 19, 2019, 164 days after the submission was received.
What is the product code of K183090?
The FDA product code is QGK – Balloon, Nasal Airway, a Class I (low risk) device regulated under 21 CFR 874.4420.