20 Micron High Capacity Trans/Filter

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K830057 ↗

FDA Product Code

CAK

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Travenol Laboratories, S.A. →

• What is the primary function of the 20 Micron High Capacity Trans/Filter?

  This device is a microfilter specifically designed to filter blood components during transfusion procedures to ensure the removal of particulate matter.

• What is the regulatory status of this blood transfusion filter?

  The device has received FDA 510(k) clearance under the number K830057, confirming it is substantially equivalent to legally marketed predicate devices.

• Under which medical specialty is this device classified?

  The 20 Micron High Capacity Trans/Filter is classified under the General Hospital medical specialty, specifically falling under regulation number 880.5440.