510(k) K081472 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
| Applicant | AngioDynamics, Inc., Queensburgy NY, US |
| Decision | Substantially Equivalent, Sep 23, 2008 |
| Received | May 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2009 | Angiodynamics, INC SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated
The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.