Blood Filter, MICROEMBOLI-ATS-F10
FDA 510(k) K780145 · Sorensen Research
510(k) numberK780145
Submission
- Device name
- Blood Filter, MICROEMBOLI-ATS-F10
- Applicant
- Sorensen Research
Mchenry, IL, US - Received
- January 30, 1978
- Decision date
- February 2, 1978
- 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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Questions and answers
When was Blood Filter, MICROEMBOLI-ATS-F10 cleared by the FDA?
Blood Filter, MICROEMBOLI-ATS-F10 (K780145) received a 510(k) decision of Substantially Equivalent on February 2, 1978, 3 days after the submission was received.
What is the product code of K780145?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.