Identity
- Trade Name
- RELIEVA TRACT FDA UDI
- Generic Name
- Nasal/paranasal balloon catheter FDA UDI
- Device Name
- RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM FDA UDI
- Model / Reference
- RT1640A FDA UDI
- Description
- RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM FDA UDI
Identifiers
- Catalog Number
- RT1640A FDA UDI
- Primary DI / UDI-DI
- 10705031462649 FDA UDI
- 510(k) Number
- K183090 FDA UDI
- FDA Product Code
- QGK FDA UDI
- GMDN Term
- Nasal/paranasal balloon catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nasal/paranasal balloon catheter
Relieva Tract by Acclarent, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal/paranasal balloon catheter.
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- VenSure Balloon Dilation System — Fiagon GmbH · Class I
- VenSure Nav Balloon Dilation System — Fiagon GmbH · Class I
- BB 8 Sinus Dilation Kit — Excelent, Inc. · Class I
- NuVent ™ — MEDTRONIC XOMED, INC. · Class I
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Acclarent, Inc.
Sources (1)
- FDA UDI 9ce10360-a6e1-477f-af63-1ef5f0338321 37 fields · synced May 30, 2026