Interface Transfusion Blood Filter #35
FDA 510(k) K851370 · Medical, Inc.
510(k) numberK851370
Submission
- Device name
- Interface Transfusion Blood Filter #35
- Applicant
- Medical, Inc.
Inver Grove Heights, MN, US - Received
- April 5, 1985
- Decision date
- June 27, 1985
- 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 Interface Transfusion Blood Filter #35 cleared by the FDA?
Interface Transfusion Blood Filter #35 (K851370) received a 510(k) decision of Substantially Equivalent on June 27, 1985, 83 days after the submission was received.
What is the product code of K851370?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.