# K210664: DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

- Pathway: 510(k) (Traditional)
- Applicant: Ra Medical Systems,Inc
- Decided: Jul 27, 2021 after 144 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: 8 generations back to K890505 (1989). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170349: RA-308 Excimer Laser System, Excimer Laser Catheter, Ra Medical Systems,Inc (2017) Summary page 4.

## Most influential descendants
- K220544: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K210664
Methodology: https://510kreport.com/methodology