510(k) K122431 ยท DYB Introducer, Catheter
HEARTSPAN STEERABLE INTRODUCER KIT
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jan 29, 2013 |
| Received | Aug 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122431
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.