510(k) K062414 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
| Applicant | Rita Medical Systems, Inc., Manchester GA, US |
| Decision | Substantially Equivalent, Feb 1, 2007 |
| Received | Aug 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2021 | Angiodynamics Inc. (Navilyst Medical Inc.) Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutrition Terminated |
LJT | None listed |
| Oct 13, 2011 | Angiodynamics, INC 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF;
AngioDynamics, INC.
The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyurethane Catheters and Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.