DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)— 510(k) K220544

Name: FDA 510(k) clearance K220544
Creator: U.S. Food and Drug Administration
Published: 2022-06-29

Substantially Equivalent

Ra Medical Systems,Inc

FDA 510(k) clearance K220544 for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0), Substantially Equivalent on 2022-06-29. Applicant: Ra Medical Systems,Inc. Device class: 2.

Clearance details

Applicant: Ra Medical Systems,Inc
Product code: Code PDU
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2022-02-25
Decision date: 2022-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.