510(k) K032835 ยท LKF Cannula, Manipulator/Injector, Uterine
H/S CATHETER SET
| Applicant | Catheter Research, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 11, 2003 |
| Received | Sep 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032835
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2015 | Catheter Research, Inc HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use. Terminated |
HGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.