# K190525: RELIEVA ULTIRRA Sinus Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: May 3, 2019 after 60 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K936109 (1994). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111254: Relieva Solo Elite Sinus Balloon Catheter, Acclarent, Inc. (2011) Summary page 4.

## Indications for use
The RELIEVA ULTIRRA® Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. The RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunction with TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. It is NOT intended to irrigate from within a target sinus for therapeutic procedures nor to facilitate diagnostic procedures with TruDi™ NAV Wire.

Source page: https://510kreport.com/device/K190525
Methodology: https://510kreport.com/methodology