510(k) K220544
K220544 is an FDA 510(k) premarket notification submitted by Ra Medical Systems,Inc for the device "DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)". The FDA issued a decision of Substantially Equivalent on June 29, 2022. The device falls under product code PDU (Catheter For Crossing Total Occlusions), a Class II device regulated under 21 CFR 870.1250. Ra Medical Systems,Inc has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2022
- Date Received
- February 25, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter For Crossing Total Occlusions
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
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.