ATI PLASMA PUMP (PP-04)
FDA 510(k) clearance K961137 · decided 1996-06-14
Clearance details
- K-number
- K961137
- Device name
- ATI PLASMA PUMP (PP-04)
- Applicant
- Apheresis Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-21
- Decision date
- 1996-06-14
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FIR
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Palm Harbor, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INFUSION PUMP (K831953) | Cryosan, Inc. | 1983-07-19 |
| ASAHI BLOOD/PLASMA PUMP #ABP-01A & (K830818) | Parker Hannifin Corp. | 1983-04-12 |
| SPS-SINGLE PATIENT SYSTEM (K821139) | Extracorporeal Medical Specialities, Inc. | 1982-05-10 |
| BLOOD PUMP-MODE S10K (K780410) | 3M Health Care, Sarns | 1978-05-03 |
| RS-7800 MINIPUMP (K771705) | Renal Systems, Inc. | 1977-10-04 |
| HEPARIN PUMP (K761050) | Dws, Inc. | 1976-12-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange t recall (Z-2149-2012) | Apheresis Technologies, Inc. | 2012-08-06 |
| Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, recall (Z-1897-2009) | Apheresis Technologies, Inc. | 2009-08-27 |