# K170941: RX NC Takeru PTCA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: KANEKA Corporation
- Decided: Jul 7, 2017 after 99 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: 1 generation back to P860019 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 5.

## Indications for use
The RX NC 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 is also indicated for the post-delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K170941
Methodology: https://510kreport.com/methodology