Panels › Gastroenterology, Urology › Product code FIR · Class 2
Pump, Blood, Extra-Luminal
Regulation 876.5820
0510(k)s in 12 months (7 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in FIR
| Company | 510(k)s | Recalls |
|---|---|---|
| Apheresis Technologies, Inc. | 1 | 3 |
| 3M Health Care, Sarns | 1 | 0 |
| Cryosan, Inc. | 1 | 0 |
| Dws, Inc. | 1 | 0 |
| Extracorporeal Medical Specialities, Inc. | 1 | 0 |
| Parker Hannifin Corp. | 1 | 0 |
| Renal Systems, Inc. | 1 | 0 |
| 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 | K961137 |
| May 24, 2012 | Apheresis Technologies, Inc. PlasmaPrO"
Plasma Pump Model PP-05
Product Usage:
The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators 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 | K961137 |
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