# K113468: Elm Pta Ballon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Creagh Medical, Ltd.
- Decided: Dec 20, 2011 after 28 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.
No later device cites it as a predicate yet.
0 of 10 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 1.

## Indications for use
The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and the renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K113468
Methodology: https://510kreport.com/methodology