Ultipor Pre-Bypass Plus Filter W/Posidyne Membrane
FDA 510(k) K875094 · Pall Biomedical Products Co.
510(k) numberK875094
Submission
- Device name
- Ultipor Pre-Bypass Plus Filter W/Posidyne Membrane
- Applicant
- Pall Biomedical Products Co.
Glen Cove, NY, US - Received
- December 10, 1987
- Decision date
- February 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRJ – Filter, Prebypass, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4280
- Specialty
- Cardiovascular
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990276 | Porous Media DPB30 Series Disposable Pre-Bypass FilterKRJ · Traditional | Porous Media Corp. | 10/01/1999SE |
| K982385 | Porous Media DPB20 Series Disposable Pre-Bypass FilterKRJ · Traditional | Porous Media Corp. | 02/01/1999SE |
| K940126 | Avecor Pre-Bypass FilterKRJ · Traditional | Avecor Cardiovascular, Inc. | 06/28/1994SE |
| K900672 | Prebypass Filter, Cat. No. FPB-5KRJ · Traditional | American Omni Medical, Inc. | 04/03/1990SE |
| K885154 | Intersept* Crystalloid Cardioplegia Deliv. SystemKRJ · Traditional | Medtronic Blood Systems, Inc. | 02/22/1989SE |
| K884390 | Intersept* Crystalloid Cardioplegia FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 12/21/1988SE |
| K884244 | Intersept* Prebypass FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 12/05/1988SE |
| K883086 | Intersept*Prebypass FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 09/16/1988SE |
| K871350 | Prebypass FilterKRJ · Traditional | American Omni Medical, Inc. | 06/08/1987SE |
| K861226 | Interface Crystalloid Cardioplegic Filter Model 70KRJ · Traditional | Medical, Inc. | 06/02/1986SE |
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| K875095 | Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional | 02/29/1988SE |
| K873667 | Pall Leukocyte Removal Filter, PlateletsCAK · Traditional | 01/06/1988SE |
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Questions and answers
When was Ultipor Pre-Bypass Plus Filter W/Posidyne Membrane cleared by the FDA?
Ultipor Pre-Bypass Plus Filter W/Posidyne Membrane (K875094) received a 510(k) decision of Substantially Equivalent on February 29, 1988, 81 days after the submission was received.
What is the product code of K875094?
The FDA product code is KRJ – Filter, Prebypass, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4280.