# K972076: Epi-Max Epistaxis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Products, Inc.
- Decided: Jun 26, 1997 after 23 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. The FDA summary names its predicate without a number.
- (no number) Product No. 20-10700 manufactured by Invotec International, Inc.: named in the summary without a submission number

## Indications for use
1. To be used for control of anterior and posterior nasal epistaxis. 2. To be used as a nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.

Source page: https://510kreport.com/device/K972076
Methodology: https://510kreport.com/methodology