Arterial Blood Filter BF-37

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802755 ↗

FDA Product Code

DTM

Device Class

Class II

Regulation

21 CFR Part 870.4260

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Delta Medical Industries →

• What clinical procedures is the Arterial Blood Filter BF-37 designed to support during use in cardiopulmonary bypass systems?

  The BF-37 is specifically designed for use during cardiothoracic procedures where extracorporeal circulation is required, such as open-heart surgeries. It filters arterial blood to remove nonbiologic particles and emboli (e.g., clots or foreign material) before the blood is reintroduced into the patient’s circulation, ensuring safer perfusion during bypass.

• Is the Arterial Blood Filter BF-37 intended for reuse, or is it strictly single-use?

  The BF-37 is explicitly intended for single-use only in controlled clinical settings like operating rooms. It is supplied sterile and must be handled under aseptic conditions to prevent contamination, which aligns with its classification as a Class II device under FDA regulation 870.4260.

• How should the BF-37 be stored to maintain its sterility and functionality?

  The device must be stored according to the manufacturer’s guidelines to preserve sterility and performance. Since it is supplied sterile in its packaging, it should remain unopened until use and kept in a clean, dry environment away from direct sunlight or extreme temperatures, as per Delta Medical Industries’ recommendations.

• Can the Arterial Blood Filter BF-37 be used in environments where MRI scans are performed?

  No, the BF-37 is not intended for use in MRI environments. The device’s design and materials are not compatible with magnetic resonance imaging, as explicitly noted in its regulatory documentation.

• What type of regulatory clearance does the BF-37 hold, and how was it determined?

  The BF-37 holds FDA 510(k) clearance (K802755) under the Traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This classification was determined by the FDA’s Cardiovascular (CV) Advisory Committee, confirming its compliance with safety and effectiveness standards for blood filters used in cardiopulmonary bypass systems.