510(k) K193474 ยท DQY Catheter, Percutaneous
Selectra 3D Outer Guiding Catheters
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Oct 16, 2020 |
| Received | Dec 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193474
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.