Alpha Micron 20 Microaggregate Filter
FDA 510(k) K955515 · Alpha Therapeutic Corp.
510(k) numberK955515
Submission
- Device name
- Alpha Micron 20 Microaggregate Filter
- Applicant
- Alpha Therapeutic Corp.
Los Angeles, CA, US - Received
- December 4, 1995
- Decision date
- February 12, 1996
- 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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| K970225 | Alpha Micron 20/40 Microaggregate FilterCAK · Traditional | 02/14/1997SE |
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| K854441 | Stuart Gilman's Weight Loss PlanLDQ · Traditional | 02/10/1986SE |
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Questions and answers
When was Alpha Micron 20 Microaggregate Filter cleared by the FDA?
Alpha Micron 20 Microaggregate Filter (K955515) received a 510(k) decision of Substantially Equivalent on February 12, 1996, 70 days after the submission was received.
What is the product code of K955515?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.