# K220544: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Ra Medical Systems,Inc
- Decided: Jun 29, 2022 after 124 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- 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: 9 generations back to K890505 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210664: DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101), Ra Medical Systems,Inc (2021) Summary page 4.

## Indications for use
The DABRA Excimer Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

Source page: https://510kreport.com/device/K220544
Methodology: https://510kreport.com/methodology