510(k) K210664 ยท PDU Catheter For Crossing Total Occlusions
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
| Applicant | Ra Medical Systems,Inc, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 27, 2021 |
| Received | Mar 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210664
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.