RA-308 Excimer Laser System, Excimer Laser Catheter— 510(k) K170349

Substantially Equivalent

Ra Medical Systems,Inc

FDA 510(k) clearance K170349 for RA-308 Excimer Laser System, Excimer Laser Catheter, Substantially Equivalent on 2017-05-24. Applicant: Ra Medical Systems,Inc.

Clearance details

Applicant: Ra Medical Systems,Inc
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2017-02-03
Decision date: 2017-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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.