# K023337: Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 18, 2002 after 42 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 6 cite it directly.
0 of 17 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

## Most influential descendants
- K131234: Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) (2013), 5 descendants of its own
- K090660: Airway Balloon Catheter Inflation Device (2009), 4 descendants of its own
- K170759: CRE Pulmonary Balloon Dilatation Catheter (2017), 2 descendants of its own
- K142934: CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved (2015), 2 descendants of its own
- K161392: Elation Pulmonary Balloon Dilation (2016), 1 descendant of its own

## Indications for use
The CRE Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.

Source page: https://510kreport.com/device/K023337
Methodology: https://510kreport.com/methodology