510(k) K961137 ยท FIR Pump, Blood, Extra-Luminal
ATI PLASMA PUMP (PP-04)
| Applicant | Apheresis Technologies, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Jun 14, 1996 |
| Received | Mar 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2012 | Apheresis Technologies, Inc. Plasma Pump Model PP-04a
Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange. Terminated |
FIR | None listed |
| Aug 27, 2009 | Apheresis Technologies, Inc. Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging.
Used with Asahi Plasma Separators to perform therapeutic Terminated |
FIR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.