510(k) K192313 ยท DYB Introducer, Catheter
Halo One Thin-Walled Guiding Sheath
| Applicant | C.R. Bard, Inc., Enniscorthy, IE |
| Decision | Substantially Equivalent, Dec 19, 2019 |
| Received | Aug 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192313
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.