Cobe SmarXT VVR 4000 Filtered Hardshell Venous Reservoir

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

510(k) Number

K002591 ↗

FDA Product Code

DTP

Device Class

Class II

Regulation

21 CFR Part 870.4230

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Cobe Cardiovascular, Inc. →

• What types of surgical procedures is this venous reservoir designed for, and why is it considered single-use only?

  The Cobe SmarXT VVR 4000 Filtered Hardshell Venous Reservoir is specifically designed for adult surgical procedures requiring cardiopulmonary bypass circuits, where blood storage and filtration are critical. It is classified as single-use due to its sterile packaging and integrated components like the defoamer and cardiotomy filter, which cannot be reliably sterilized or reused without compromising performance or safety.

• How is this device supplied, and what storage instructions should be followed to maintain its integrity?

  The device is supplied as a standalone, sterile component, ready for immediate use in cardiopulmonary bypass circuits. To preserve sterility, it should be stored following standard sterile surgical instrument protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures, and protected from physical damage until use.

• Does this venous reservoir require any special handling considerations, such as compatibility with MRI equipment?

  No, the Cobe SmarXT VVR 4000 does not require special MRI safety considerations. It is designed for use in surgical settings where MRI compatibility is not a concern, as it is not intended for procedures involving magnetic resonance imaging.

• What regulatory pathway does this device follow, and how does that affect its use in clinical settings?

  This device follows the FDA 510(k) clearance pathway (K002591) and is classified as a Class II medical device under the DTP product code. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device, ensuring it meets established safety and performance standards for cardiopulmonary bypass applications in adult surgical procedures.