510(k) K043525 ยท DYB Introducer, Catheter
CATHETER INTRODUCER
| Applicant | Galt Medical Corp., Garland TX, US |
| Decision | Substantially Equivalent, Feb 9, 2005 |
| Received | Dec 21, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2025 | Galt Medical Corporation B Braun Interventional ELITE HV Hemostasis Valve Introducer System
REF 612802
Model Number: BCL-100-04
The Elite HV Introducer System is indicated for use in percutaneous
procedures to introduce cath Open, Classified |
DYB | None listed |
| May 2, 2018 | Galt Medical Corporation 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36;
2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog Terminated |
DYB | None listed |
| May 2, 2018 | Galt Medical Corporation Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.