510(k) K240787 ยท DQY Catheter, Percutaneous
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Sep 12, 2024 |
| Received | Mar 22, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240787
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.