# K170759: CRE Pulmonary Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jun 23, 2017 after 102 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
Longest line of descent: 1 generation back to K023337 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023337: Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350, Boston Scientific Corp (2002) Summary page 4.

## Most influential descendants
- K222187: Multistage Balloon Dilatation Catheter (2023), 0 descendants of its own
- K211894: Trachealator (2021), 0 descendants 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/K170759
Methodology: https://510kreport.com/methodology