Cardiotomy Reservoir CR-2000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790116 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Cardiotomy Reservoir CR-2000 during surgery?

  The Cardiotomy Reservoir CR-2000 is designed specifically for temporary collection and storage of blood during cardiotomy procedures. Its main function is to manage cardiotomy suction while helping prevent air embolism by maintaining a closed-loop system for blood retrieval, ensuring safe handling of blood during cardiac surgeries.

• Is the Cardiotomy Reservoir CR-2000 intended for reuse, or is it meant for single-use only?

  The CR-2000 is explicitly intended for single-use in operating room settings. This design ensures sterility and safety, as it is supplied sterile and not meant to be reused after a single surgical procedure.

• How should the Cardiotomy Reservoir CR-2000 be stored before use, and what are the key storage requirements?

  The device must be stored in a clean, dry environment prior to use. This ensures its integrity and readiness for sterile surgical procedures, as it is supplied sterile and designed for single-use in the operating room.

• Can the Cardiotomy Reservoir CR-2000 be used in an MRI environment, or are there any restrictions?

  The CR-2000 is explicitly labeled as not MRI-compatible, meaning it should not be used in or near MRI machines. This restriction is critical to avoid potential risks to patients or interference with imaging equipment.

• What regulatory pathway does the Cardiotomy Reservoir CR-2000 follow, and how is it classified by the FDA?

  The CR-2000 is regulated under the FDA’s 510(k) clearance process (K790116) and is classified as a surgical suction device under 21 CFR 870.3680. While it is formally listed under the FDA’s nomenclature as a *Permanent Pacemaker Electrode*, its primary function is for cardiotomy suction and blood management during cardiac surgeries.