# K211044: Sublime Radial Access 018 RX Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,
- Decided: Jun 16, 2021 after 69 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 K042537 (2004). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200700: Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter, Creagh Medical, Ltd. (2020) Summary page 4.

## Indications for use
The O 18 Radial Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis 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/K211044
Methodology: https://510kreport.com/methodology