Relieva Tract

FDA UDI

Class I (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name: RELIEVA TRACT FDA UDI
Generic Name: Nasal/paranasal balloon catheter FDA UDI
Device Name: RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM - 1PK FDA UDI
Model / Reference: RT1040AZ FDA UDI
Description: RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM - 1PK FDA UDI

Identifiers

Catalog Number: RT1040AZ FDA UDI
Primary DI / UDI-DI: 20705031462592 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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.

XprESS Ultra — Stryker Corp. · Class I
VenSure Light Balloon Dilation System — Fiagon GmbH · Class I
NuVent ™ — MEDTRONIC XOMED, INC. · Class I
NuVent ™ — MEDTRONIC XOMED, INC. · Class I
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

K183090 also covers:

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 dcc32489-a970-44da-ae01-23828defacba 37 fields · synced May 30, 2026