# K971411: Disposable Silicone Epistaxis Catheter V-27030/Disposable Silicone Epistaxis Catheter Kit V-27030K

- Pathway: 510(k) (Traditional)
- Applicant: Bentec Medical, Inc.
- Decided: Jun 3, 1997 after 48 days
- Product code: EMX (Balloon, Epistaxis)
- Device class: 1
- Regulation: 21 CFR 874.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The catheter is designed to aid-in'controlling nasat hemorrhage due to trauma fromr injury. The device may also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Source page: https://510kreport.com/device/K971411
Methodology: https://510kreport.com/methodology