510(k) K093796 ยท PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
ASEPT PERITONEAL DRAINAGE SYSTEM
| Applicant | Pfm Medical, Inc., Oceanside CA, US |
| Decision | Unknown, Feb 26, 2010 |
| Received | Dec 11, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Pfm Medical Inc ASEPT 2000 ml Drainage Bag, Ref No. 622280
Product Usage:
The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only. Terminated |
FJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.