Filter, Arterial Blood W/Tubing Bypass

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K781707 ↗

FDA Product Code

DTM

Device Class

Class II

Regulation

21 CFR Part 870.4260

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Edge Protector, Barrier

  Class II

  FDA 510(k) K790306 Active Cleared 22 Feb 1979

• Barrier Pediatric/Incise Drape 450

  Class II

  FDA 510(k) K780839 Active Cleared 14 Aug 1978

• Barrier General Surgery Pack

  Class II

  FDA 510(k) K760807 Active Cleared 3 Nov 1976

• Barrier Antimicrobial Incise Drape

  Class II

  FDA 510(k) K820543 Active Cleared 22 Jul 1982

• Purge Line Unit

  Class II

  FDA 510(k) K790804 Active Cleared 25 May 1979

• Sterile Surgical Scrub Brush

  Class I

  FDA 510(k) K874653 Active Cleared 30 Dec 1987

See all devices from Surgikos, Inc. →

• What is the Surgikos Arterial Blood Filter with Tubing Bypass used for?

  This device is designed to filter nonbiologic particles and emboli—such as blood clots or foreign material—from arterial blood during cardiopulmonary bypass procedures. It ensures blood purity by integrating into the arterial return line of gas exchange (oxygenator) systems, preventing obstruction in circulation and maintaining safe blood flow during cardiac surgeries.

• Is the Surgikos Arterial Blood Filter with Tubing Bypass intended for reuse?

  No, the filter is explicitly supplied as a single-use device. Single-use design ensures sterility and safety for each procedure, reducing the risk of contamination or cross-infection between patients. It is intended for use in controlled clinical settings like operating rooms during cardiac surgeries only.

• What regulatory pathway does this device follow?

  The Surgikos Arterial Blood Filter with Tubing Bypass is cleared by the FDA under a 510(k) submission (K781707) through traditional review. It is classified as a Class II device under special controls (regulation number 870.4260) and is intended for cardiovascular applications, adhering to medical specialty standards for cardiopulmonary bypass systems.

• How is the filter supplied, and what sterility assurances are provided?

  The filter is supplied sterile and packaged for single-use only. Sterility is maintained through manufacturing controls and packaging designed to preserve integrity until first use. It is not intended for reprocessing or reuse, ensuring consistent performance and patient safety in each procedure.

• Are there multiple models or sizes available for this filter?

  The provided data lists multiple FEI numbers (e.g., 1000138054, 3002807091) and registration numbers, which typically correspond to different lot or batch identifiers rather than distinct models or sizes. These identifiers are used for tracking and regulatory compliance but do not imply variations in physical dimensions or functionality. Confirmation of specific sizes or models should be obtained directly from Surgikos, Inc.