510(k) K192996 ยท DQY Catheter, Percutaneous
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Nov 21, 2019 |
| Received | Oct 28, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192996
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.