510(k) K062852 ยท DYB Introducer, Catheter
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
| Applicant | Onset Medical Corporation, Mission Viejo CA, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | Sep 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062852
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.