Pall 3N1 Filter
FDA 510(k) K905794 · Pall Biomedical Products Co.
510(k) numberK905794
Submission
- Device name
- Pall 3N1 Filter
- Applicant
- Pall Biomedical Products Co.
Glen Cove, NY, US - Received
- December 27, 1990
- Decision date
- June 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPB – Filter, Infusion Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K021293 | Arteria Blood FilterFPB · Traditional | Arteria Medical Science, Inc. | 08/22/2002SE |
| K993379 | Pall Supor Aef FilterFPB · Traditional | Pall Corp. | 12/16/1999SE |
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| K954331 | Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)FPB · Traditional | Pall Biomedical Products Co. | 01/09/1997SE |
| K933523 | I.V. Filter SetFPB · Traditional | Mediziv Medical Products 1987 , Ltd. | 05/19/1995SE |
More from Mediziv Medical Products 1987 , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 |
| K874405 | Pall Stat Prime(Tm) Blood Filter for Extra. UseJOD · Traditional | 12/30/1987SE |
| K853987 | Pall Ec Plus 3LPM Max. Filter W/SleeveDTM · Traditional | 12/11/1985SE |
Questions and answers
When was Pall 3N1 Filter cleared by the FDA?
Pall 3N1 Filter (K905794) received a 510(k) decision of Substantially Equivalent on June 13, 1991, 168 days after the submission was received.
What is the product code of K905794?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.