510(k) K153533 ยท DYB Introducer, Catheter
Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
| Applicant | Galt Medical Corp., Garland TX, US |
| Decision | Substantially Equivalent, Jul 5, 2016 |
| Received | Dec 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2023 | Galt Medical Corporation Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 Open, Classified |
DYB | None listed |
| Jun 15, 2023 | Galt Medical Corporation Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk) Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.