DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
FDA 510(k) K220544 · Ra Medical Systems,Inc
510(k) numberK220544
Submission
- Device name
- DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
- Applicant
- Ra Medical Systems,Inc
Carlsbad, CA, US - Received
- February 25, 2022
- Decision date
- June 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
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|---|---|---|---|
| K262013 | Kiba CTO Crossing CatheterPDU · Special | Reflow Medical, Inc. | 08/28/2026SE |
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| K251158 | PowerWire® 14 Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 09/11/2025SESK |
| K251376 | LimFlow ARCPDU · Special | LimFlow, Inc. | 05/31/2025SE |
| K232562 | PowerWire Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 02/28/2024SESK |
| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | Soundbite Medical Solutions, Inc. | 08/28/2023SE |
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 04/25/2023SE |
| K221163 | Tunnel Crossing CatheterPDU · Traditional | Tractus Vascular, LLC | 01/19/2023SE |
| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
| K211802 | GoBack Crossing CatheterPDU · Traditional | Upstream Peripheral Technologies, Ltd. | 03/01/2022SE |
More from Upstream Peripheral Technologies, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)PDU · Traditional | 07/27/2021SE |
| K170349 | RA-308 Excimer Laser System, Excimer Laser CatheterPDU · Traditional | 05/24/2017SE |
| K062963 | Pharos Excimer Laser System, Model EX-308GEX · Traditional | 04/03/2007SE |
Questions and answers
When was DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) cleared by the FDA?
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) (K220544) received a 510(k) decision of Substantially Equivalent on June 29, 2022, 124 days after the submission was received.
What is the product code of K220544?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.