Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)
FDA 510(k) K954331 · Pall Biomedical Products Co.
510(k) numberK954331
Submission
- Device name
- Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)
- Applicant
- Pall Biomedical Products Co.
East Hills, NY, US - Received
- September 15, 1995
- Decision date
- January 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K873667 | Pall Leukocyte Removal Filter, PlateletsCAK · Traditional | 01/06/1988SE |
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| K874405 | Pall Stat Prime(Tm) Blood Filter for Extra. UseJOD · Traditional | 12/30/1987SE |
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Questions and answers
When was Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter) cleared by the FDA?
Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter) (K954331) received a 510(k) decision of Substantially Equivalent on January 9, 1997, 482 days after the submission was received.
What is the product code of K954331?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.