510(k) K983085 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
HEMOCOR HPH 700 HEMOCONCENTRATOR
| Applicant | Minntech Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 13, 1998 |
| Received | Sep 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983085
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2015 | Medivators, Inc. Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide
The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during an Terminated |
KDI | None listed |
| 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.