DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)— 510(k) K210664

Name: FDA 510(k) clearance K210664
Creator: U.S. Food and Drug Administration
Published: 2021-07-27

Substantially Equivalent

Ra Medical Systems,Inc

FDA 510(k) clearance K210664 for DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101), Substantially Equivalent on 2021-07-27. 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: 2021-03-05
Decision date: 2021-07-27
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.