510(k) K083873 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PICC (CT RATED AND NON-RATED)
| Applicant | Pfm Medical, Inc., Oceanside CA, US |
| Decision | Substantially Equivalent, Mar 19, 2009 |
| Received | Dec 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Pfm Medical Inc Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005
Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC cathete Terminated |
LJS | None listed |
| Dec 12, 2014 | Pfm Medical Inc 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D
Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and Terminated |
LJS | None listed |
| Dec 12, 2014 | Pfm Medical Inc ASEPT Peritoneal Drainage System, Ref No. P09080002
Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdome Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.