# K163372: RX Takeru Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: KANEKA Corporation
- Decided: Apr 7, 2017 after 127 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P790017 (1980). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860019/S208: Apex Monorail and Over-the-Wire Ptca Dilatation Catheters, Scimed Life Systems, Inc. (2008) Summary page 5.
- K143480: Euphora Rapid Exchange Balloon Dilatation Catheter, Medtronic, Inc. (2015) Summary page 5.

## Most influential descendants
- K172264: OTW Takeru PTCA Balloon Dilatation Catheter (2018), 0 descendants of its own

## Indications for use
The RX Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product (balloon models 2.0-5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K163372
Methodology: https://510kreport.com/methodology