# K171251: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Creagh Medical
- Decided: Sep 8, 2017 after 133 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: 4 generations back to K042537 (2004). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102645: Willow/Elm Pta Balloon Dilatation Catheter, Creagh Medical, Ltd. (2010) Summary page 4.

## Most influential descendants
- K200700: Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter (2020), 1 descendant of its own
- K211044: Sublime Radial Access 018 RX Dilatation Catheter (2021), 0 descendants of its own

## Indications for use
The 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, ilio-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/K171251
Methodology: https://510kreport.com/methodology