510(k) K110461 ยท DQY Catheter, Percutaneous
SELECTRA CS LEAD INTRODUCER SYSTEM
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Apr 20, 2011 |
| Received | Feb 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110461
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.