# K242419: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Creagh Medical Ltd. Dba Surmodics, Inc.
- Decided: Nov 15, 2024 after 92 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: 6 generations back to K001134 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180007: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter, Creagh Medical, Ltd. (2018) Summary page 5.

## Indications for use
The Advance Serenity 18 Hydrophilic 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/K242419
Methodology: https://510kreport.com/methodology