510(k) K131978 ยท DQY Catheter, Percutaneous
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Aug 23, 2013 |
| Received | Jun 28, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131978
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.