Pall Stat Prime(Tm) Blood Filter for Extra. Use
FDA 510(k) K874405 · Pall Biomedical Products Co.
510(k) numberK874405
Submission
- Device name
- Pall Stat Prime(Tm) Blood Filter for Extra. Use
- Applicant
- Pall Biomedical Products Co.
Glen Cove, NY, US - Received
- October 28, 1987
- Decision date
- December 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4270
- Specialty
- Cardiovascular
Other 510(k)s with product code JOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993060 | Gas FilterJOD · Traditional | Olson Medical Sales, Inc. | 03/28/2000SE |
| K890504 | Cardiotomy/Autotransfusion/Pleural Drainage VenousJOD · Traditional | Gish Biomedical, Inc. | 03/10/1989SE |
| K875095 | Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional | Pall Biomedical Products Co. | 02/29/1988SE |
| K855067 | Swank Cardiotomy Suction Line Blood Filter CA100JOD · Traditional | Cobe Laboratories, Inc. | 02/26/1986SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | Sterile Design, Inc. | 10/15/1984SE |
| K830634 | Cardiotomy FilterJOD · Traditional | Texas Medical Products, Inc. | 06/30/1983SE |
| K823260 | Interface Cardiotomy Blood Filter #51JOD · Traditional | Medical, Inc. | 11/24/1982SE |
| K823259 | Interface Cardiotomy Blood Filter #50JOD · Traditional | Medical, Inc. | 11/24/1982SE |
| K812243 | Interface Cardiotomy Blood Filter #51JOD · Traditional | Medical, Inc. | 08/25/1981SE |
| K781383 | Interface Cardiotomy Blood FilterJOD · Traditional | Medical, Inc. | 09/27/1978SE |
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| K954331 | Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)FPB · Traditional | 01/09/1997SE |
| K960993 | Pall SQ40S Blood Filter (SQ40S/SQ40ST)CAK · Traditional | 04/22/1996SE |
| K905794 | Pall 3N1 FilterFPB · Traditional | 06/13/1991SE |
| K902518 | Ld-Six Arterial Blood Filter for Extra. ServiceDTM · Traditional | 10/16/1990SE |
| K884534 | Pall Hepchek (TM) Heparin Absorption FilterJPA · Traditional | 01/24/1989SE |
| K875095 | Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional | 02/29/1988SE |
| K875094 | Ultipor Pre-Bypass Plus Filter W/Posidyne MembraneKRJ · Traditional | 02/29/1988SE |
| K873667 | Pall Leukocyte Removal Filter, PlateletsCAK · Traditional | 01/06/1988SE |
| K873666 | Pall Leukocyte Removal Filter, BloodCAK · Traditional | 01/06/1988SE |
| K853987 | Pall Ec Plus 3LPM Max. Filter W/SleeveDTM · Traditional | 12/11/1985SE |
Questions and answers
When was Pall Stat Prime(Tm) Blood Filter for Extra. Use cleared by the FDA?
Pall Stat Prime(Tm) Blood Filter for Extra. Use (K874405) received a 510(k) decision of Substantially Equivalent on December 30, 1987, 63 days after the submission was received.
What is the product code of K874405?
The FDA product code is JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4270.