Alpha Micron 20/40 Microaggregate Filter
FDA 510(k) K970225 · Alpha Therapeutic Corp.
510(k) numberK970225
Submission
- Device name
- Alpha Micron 20/40 Microaggregate Filter
- Applicant
- Alpha Therapeutic Corp.
Los Angeles, CA, US - Received
- January 17, 1997
- Decision date
- February 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAK – Microfilter, Blood Transfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K960993 | Pall SQ40S Blood Filter (SQ40S/SQ40ST)CAK · Traditional | Pall Biomedical Products Co. | 04/22/1996SE |
| K955515 | Alpha Micron 20 Microaggregate FilterCAK · Traditional | Alpha Therapeutic Corp. | 02/12/1996SE |
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| K955515 | Alpha Micron 20 Microaggregate FilterCAK · Traditional | 02/12/1996SE |
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| K854441 | Stuart Gilman's Weight Loss PlanLDQ · Traditional | 02/10/1986SE |
| K833294 | Alpha Y-Recipient SetBRZ · Traditional | 12/27/1983SE |
| K820447 | Alpha Plasma Transfer SetKSB · Traditional | 04/14/1982SE |
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Questions and answers
When was Alpha Micron 20/40 Microaggregate Filter cleared by the FDA?
Alpha Micron 20/40 Microaggregate Filter (K970225) received a 510(k) decision of Substantially Equivalent on February 14, 1997, 28 days after the submission was received.
What is the product code of K970225?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.