# K143738: DSS Sinusplasty Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Intuit Medical Products, LLC
- Decided: Aug 27, 2015 after 240 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)
- K073041: Relieva and Relieva Acella Sinus Balloon Catheter, Acclarent, Inc. (2008) Summary page 4.
- K111254: Relieva Solo Elite Sinus Balloon Catheter, Acclarent, Inc. (2011) Summary page 4.

## Indications for use
The DSS Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the 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.

Source page: https://510kreport.com/device/K143738
Methodology: https://510kreport.com/methodology