# K180007: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Creagh Medical, Ltd.
- Decided: Apr 19, 2018 after 107 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001134 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132430: Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter, Boston Scientific Corp (2013) Summary page 4.

## Most influential descendants
- K242419: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
The 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K180007
Methodology: https://510kreport.com/methodology