510(k) K093307 ยท DWM Apparatus, Suction, Patient Care
ASEPT PLEURAL DRAINAGE SYSTEM
| Applicant | Pfm Medical, Inc., Oceanside CA, US |
| Decision | Substantially Equivalent, Nov 6, 2009 |
| Received | Oct 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093307
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Pfm Medical Inc ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001
Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain acc Terminated |
DWM | None listed |
| Dec 12, 2014 | Pfm Medical Inc ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052
Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from t Terminated |
DWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.