# K983373: Impact Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun/Mcgaw
- Decided: Jun 22, 1999 after 271 days
- Product code: KNQ (Dilator, Esophageal)
- Device class: 2
- Regulation: 21 CFR 876.5365
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0509-2010: The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The produc

## Indications for use
The Impact balloon dilation catheter is indicated for use in adult and adolescent patients to dilate esophageal strictures due to: esophageal surgery, primary gastroesophageal reflux, radiation therapy.

Source page: https://510kreport.com/device/K983373
Methodology: https://510kreport.com/methodology