DeviceClearance

K170349

Substantially Equivalent

RA-308 Excimer Laser System, Excimer Laser Catheter

Applicant
Ra Medical Systems,Inc
Product code
PDU
Advisory panel
Cardiovascular
Date received
Decision date
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, through . 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.