Swank Blood Transfusion Micro-Filter W/Straight SE

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K855064 ↗

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 Cobe Laboratories, Inc. →

• What is the Swank Blood Transfusion Micro-Filter W/Straight SE used for?

  It is designed for blood transfusion procedures to filter blood, as defined by its device name and FDA product code CAK (Microfilter, Blood Transfusion), and is intended for use in general hospital settings.

• Is the Swank Blood Transfusion Micro-Filter W/Straight SE reusable or single-use?

  The device is supplied as a single-use device, with no indication of reusability provided in the data, meaning it is intended for one-time use only during transfusion procedures.

• What regulatory pathway was used for the Swank Blood Transfusion Micro-Filter W/Straight SE?

  The device received traditional 510(k) clearance (K855064) from the FDA on March 12, 1986, indicating it was cleared via the traditional 510(k) process as substantially equivalent to a predicate device.

• Who manufactures the Swank Blood Transfusion Micro-Filter W/Straight SE?

  The device is manufactured by Cobe Laboratories, Inc., as stated in the manufacturer field and confirmed by the applicant and FEI numbers in the openfda data.