510(k) K202226 ยท DYB Introducer, Catheter
Lim Precision Steerable TS, Steerable Sheath, Dilator
| Applicant | Keystone Heart, Ltd., Caesaria, IL |
| Decision | Substantially Equivalent, Dec 15, 2020 |
| Received | Aug 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202226
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.