DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
FDA 510(k) K210664 · Ra Medical Systems,Inc
510(k) numberK210664
Submission
- Device name
- DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
- Applicant
- Ra Medical Systems,Inc
Carlsbad, CA, US - Received
- March 5, 2021
- Decision date
- July 27, 2021
- 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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| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 04/25/2023SE |
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| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional | Ra Medical Systems,Inc | 06/29/2022SE |
More from Ra Medical Systems,Inc
| 510(k) | Device | Decision |
|---|---|---|
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional | 06/29/2022SE |
| 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 Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) cleared by the FDA?
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) (K210664) received a 510(k) decision of Substantially Equivalent on July 27, 2021, 144 days after the submission was received.
What is the product code of K210664?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.