510(k) K132177 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
MEDCOMP GEN III POWER INJECTABLE PORT
| Applicant | Medcomp ( Medical Components), Harleysville PA, US |
| Decision | Substantially Equivalent, Dec 12, 2013 |
| Received | Jul 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2021 | Medical Components, Inc dba MedComp Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system. Open, Classified |
LJT | None listed |
| Nov 22, 2017 | Medical Components, Inc dba MedComp 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter Terminated |
LJT | None listed |
| May 25, 2017 | Medical Components, Inc dba MedComp 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157
Product Usage:
Indicated for patient therapies requiring repeated acce Terminated |
LJT | None listed |
| Mar 8, 2017 | Medical Components, Inc dba MedComp 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter
The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.