510(k) K183265 ยท DQY Catheter, Percutaneous
Selectra Catheters, Selectra Accessory Kit
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Dec 13, 2018 |
| Received | Nov 23, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183265
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.