510(k) K120212 ยท DYB Introducer, Catheter
AFX INTRODUCER SYSTEM
| Applicant | Endologix, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 9, 2012 |
| Received | Jan 24, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2013 | Endologix Inc Brand Name: AFX" Introducer System, Model Number S17-45.
Lot Numbers: 1079840, 1079843, 1079844, 1079845.
Product Usage:
The AFX Introducer System is intended for use to facilitate the introduction o Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.