510(k) K153246 ยท DYB Introducer, Catheter
PTFE Super Sheath Introducer 2.1
| Applicant | Medcomp (Medical Components, Inc.), Harleysville PA, US |
| Decision | Substantially Equivalent, Feb 12, 2016 |
| Received | Nov 9, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153246
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.