# K161698: Relieva UltirraNav Sinus Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Oct 24, 2016 after 126 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: 16 generations back to K936109 (1994). 83 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 85 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.
- K132297: EM Sinus Dilation System, Medtronic Xomed, Inc. (2013) Summary page 4.

## Most influential descendants
- K172737: MESIRE - Balloon Sinus Dilatation System (2017), 0 descendants of its own

## Indications for use
The Relieva UltirraNav™ Sinus Balloon Catheter is an instrument intended to dilate the sinus ostia and spaces within the maxillary, frontal, and sphenoid paranasal sinus cavities for diagnostic and therapeutic 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. The Relieva UltirraNav™ Sinus Balloon Catheter may be utilized in conjunction with the NavWire Sinus Navigation Guidewire and CARTO® ENT System to to confirm placement in the accessed anatomy relative to pre-acquired CT images.

Source page: https://510kreport.com/device/K161698
Methodology: https://510kreport.com/methodology