# K974788: Cre (TM) Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 20, 1998 after 88 days
- Product code: KNQ (Dilator, Esophageal)
- Device class: 2
- Regulation: 21 CFR 876.5365
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices 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) CRE™ Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Vector TTS™ Balloon Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K110833: Cre Balloon Dilatation Catheter (2011), 17 descendants of its own
- K112994: Cre Ditatation Ballon (2012), 15 descendants of its own
- K151671: Disposable Multistage Dilation Balloon Catheter (2015), 4 descendants of its own
- K162226: Reliant Multistage Dilatation Balloon Catheter (2017), 3 descendants of its own
- K180418: Reliant (TM) Multistage Dilatation Balloon Catheter (2018), 2 descendants of its own

## Indications for use
The Modified Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label.* * The recommended application on the label may refer to any combination of esophageal, pyloric, and colonic dilatation.

Source page: https://510kreport.com/device/K974788
Methodology: https://510kreport.com/methodology