# K170349: RA-308 Excimer Laser System, Excimer Laser Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ra Medical Systems,Inc
- Decided: May 24, 2017 after 110 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K890505 (1989). 26 ancestors in all.
2 later devices descend 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)
- K040067: Clirpath Excimer Laser Catheter, Spectranetics Corp. (2004) Summary page 4.

## Most influential descendants
- K210664: DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) (2021), 1 descendant of its own
- K220544: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) (2022), 0 descendants of its own

## Recalls of this device
- Oct 16, 2020 · Class II · Z-0569-2021: Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the 
- Jul 24, 2020 · Class II · Z-0050-2021: Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
- Jan 23, 2020 · Class II · Z-2497-2020: A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur,
- Sep 19, 2019 · Class II · Z-2006-2020: The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled s
- Feb 15, 2018 · Class II · Z-2218-2019: Lasers/Catheters did not calibrate during set-up prior to use.

## 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/K170349
Methodology: https://510kreport.com/methodology