510(k) K923139 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
HEMOCOR HP HEMOCONCENTRATOR SERIES
| Applicant | Minntech Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 18, 1994 |
| Received | Jun 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923139
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2015 | Medtronic Perfusion Systems MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS.
Enables the perfusionist to manage the patient's hematocrit and fluid status. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.