510(k) K122926 ยท DYB Introducer, Catheter
SUREFLEX STEERABLE GUIDING SHEATH KIT
| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Jan 24, 2013 |
| Received | Sep 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122926
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.