510(k) K070003 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
| Applicant | Medcomp, Harleysville PA, US |
| Decision | Substantially Equivalent, May 15, 2007 |
| Received | Jan 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2012 | Medical Components, Inc dba MedComp MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter.
Power Injectable Implantable Infusion Port insertion kit. Terminated |
LJT | None listed |
| May 18, 2012 | Medical Components, Inc dba MedComp 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an impla Terminated |
LJT | None listed |
| Aug 17, 2010 | Medical Components, Inc dba MedComp medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841. Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.