# DABRA Laser System RA-308

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/dabra-laser-system-ra-308>
- Manufacturer: [Catheter Precision, Inc](https://devicerts.com/manufacturers/catheter-precision-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: PDU
- GMDN: Atherectomy excimer laser system (60389)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00842362100024 · listed 2017-10-13 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K170349 · decision 2017-05-24 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0569-2021 · Class II · terminated · initiated 2020-10-16: 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 laser to continue to lase.
- Z-0050-2021 · Class II · terminated · initiated 2020-07-24: Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
- Z-2497-2020 · Class II · terminated · initiated 2020-01-23: 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, injuring the user or patient.
- Z-2006-2020 · Class II · terminated · initiated 2019-09-19: 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 shelf life.
- Z-2218-2019 · Class II · terminated · initiated 2018-02-15: Lasers/Catheters did not calibrate during set-up prior to use.

## Identity

- Trade name: DABRA Laser System [FDA GUDID (AccessGUDID)]
- Generic name: Atherectomy excimer laser system [FDA GUDID (AccessGUDID)]
- Model / reference: RA-308 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00842362100024 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K170349 [FDA GUDID (AccessGUDID)]
- FDA product code: PDU [FDA GUDID (AccessGUDID)]
- GMDN term: Atherectomy excimer laser system (60389) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 870.1250 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: DABRA Laser System RA-308, Catheter Precision, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/dabra-laser-system-ra-308 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/dabra-laser-system-ra-308.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/dabra-laser-system-ra-308
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.