510(k) K982272 ยท DQX Wire, Guide, Catheter
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Jan 8, 1999 |
| Received | Jun 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982272
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.