510(k) K220544 ยท PDU Catheter For Crossing Total Occlusions
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
| Applicant | Ra Medical Systems,Inc, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 29, 2022 |
| Received | Feb 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220544
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.