Cardiotomy Reservoir BRS-XXX Series

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

510(k) Number

K843888 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascular Access Port/Cath Cat.#vp-Xxxx Vasport Ser

  Class II

  FDA 510(k) K854610 Active Cleared 8 May 1986

• Cps-3000 Cardioplegia Reservoir

  Class II

  FDA 510(k) K861102 Active Cleared 28 May 1986

• Tubing Connectors Ec-2XXX Series

  Class II

  FDA 510(k) K833322 Active Cleared 16 Dec 1983

• Chest Drainage Pack, CDP-1000

  Class II

  FDA 510(k) K861103 Active Cleared 28 May 1986

• Cardiotomy/Venous Reservoir No.: Cvr Series

  Class II

  FDA 510(k) K883923 Active Cleared 4 Nov 1988

• Atr-2900DF (with Depth Filter)/Cap-35DF (with Depth Filter)

  Class II

  FDA 510(k) K936286 Active Cleared 14 Feb 1994

See all devices from Gish Biomedical, Inc. →

• What is the primary purpose of the Cardiotomy Reservoir BRS-XXX Series during cardiac surgery?

  The Cardiotomy Reservoir BRS-XXX Series is designed to collect and temporarily store blood aspirated during cardiac surgical procedures, specifically during cardiopulmonary bypass operations. Its role is to ensure safe recirculation of blood while minimizing air exposure and maintaining hemodynamic stability, which is critical for patient safety during these complex surgeries.

• Is the Cardiotomy Reservoir BRS-XXX Series intended for reuse, or is it meant for single-use only?

  The device is explicitly manufactured as a single-use item. It is supplied sterile and should not be reused to prevent contamination and ensure patient safety, adhering to standard surgical instrument protocols.

• How should the Cardiotomy Reservoir BRS-XXX Series be stored to maintain its sterility and functionality?

  The device must be stored according to standard surgical instrument protocols to preserve sterility and functionality. This typically involves keeping it in a clean, dry environment, protected from physical damage, and following manufacturer guidelines to avoid compromising its sterile packaging.

• What regulatory pathway was used for FDA clearance of the Cardiotomy Reservoir BRS-XXX Series, and what class is it assigned?

  The device received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II medical device under regulation number 870.4400. This classification indicates it poses moderate risk and requires specific controls to ensure safety and effectiveness.

• Are there multiple sizes or models available for the Cardiotomy Reservoir BRS-XXX Series, and how would I identify them?

  Yes, the BRS-XXX Series includes multiple models, as indicated by the various registration numbers (e.g., 3030125051, 1000138054, etc.) in the OpenFDA data. These likely correspond to different sizes or configurations. To identify the correct model, refer to the device’s labeling or consult the manufacturer’s documentation, as each model may have specific performance characteristics suited for different surgical needs.