Alpha MICRON-40 Filter
FDA 510(k) K810761 · Alpha Therapeutic Corp.
510(k) numberK810761
Submission
- Device name
- Alpha MICRON-40 Filter
- Applicant
- Alpha Therapeutic Corp.
Mchenry, IL, US - Received
- March 20, 1981
- Decision date
- June 30, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K990310 | Charter Medical, Ltd MP 450 (40 Micron Filter)CAK · Traditional | Charter Medical, Ltd. | 08/30/1999SE |
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| K972159 | Fenwal 40 Micron Transfusion FilterCAK · Traditional | Baxter Healthcare Corp | 07/23/1997SE |
| K970225 | Alpha Micron 20/40 Microaggregate FilterCAK · Traditional | Alpha Therapeutic Corp. | 02/14/1997SE |
| 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 |
| K904223 | Sepacell(R) R-200/500 Leukocyte Removal Recip SetsCAK · Traditional | Baxter Healthcare Corp | 10/26/1990SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K970225 | Alpha Micron 20/40 Microaggregate FilterCAK · Traditional | 02/14/1997SE |
| K955515 | Alpha Micron 20 Microaggregate FilterCAK · Traditional | 02/12/1996SE |
| K854920 | Therapy CassettsMCU · Traditional | 05/19/1986SN |
| 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 |
| K810897 | Alpha Plastic Plasma BottleKSR · Traditional | 09/23/1981SE |
Questions and answers
When was Alpha MICRON-40 Filter cleared by the FDA?
Alpha MICRON-40 Filter (K810761) received a 510(k) decision of Substantially Equivalent on June 30, 1981, 102 days after the submission was received.
What is the product code of K810761?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.