# K043527: Relieva Sinus Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Exploramed Nc1, Inc.
- Decided: Apr 5, 2005 after 105 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
No predicates in its family tree.
55 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Circular Cutting Punch: named in the summary without a submission number
- (no number) Antrum Curette: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K935233: Iolab Lacrimal Duct Catheter, Chiron Vision Corp. (1994). Our reading of the summary gave K935233, FDA’s number for Iolab Lacrimal Duct Catheter (Chiron Vision Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lacricath”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K061903: Relieva Sinus Balloon Catheter (2006), 49 descendants of its own
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own
- K102003: Xpress Balloon Device (2010), 36 descendants of its own

## Indications for use
The Relieva Sinus Balloon Dilation Catheter is intended to provide a means to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K043527
Methodology: https://510kreport.com/methodology