Venous Hardshell Cardiotomy Reservoir, Model VHK 4201

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

Full name

Venous Hardshell Cardiotomy Resevoir, Model Vhk 4201

510(k) Number

K003551 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary function of the VHK 4201 reservoir in cardiac surgery?

  It acts as a collection chamber for venous blood during cardiopulmonary bypass, allowing the blood to be routed outside the body for oxygenation and circulation before returning to the patient.

• Is the VENOUS HARDSHELL CARDIOTOMY RESEVOIR supplied sterile and for single use?

  Yes, the device is provided sterile and is intended for a single‑use application, ensuring no cross‑contamination between procedures and maintaining patient safety.

• How is the VHK 4201 classified under FDA regulations and what does that imply?

  It is classified as a Class II medical device (regulation number 870.4400), meaning it requires general and special controls, including FDA 510(k) clearance, to demonstrate substantial equivalence to existing devices.

• What regulatory clearance does the VHK 4201 have and when was it granted?

  The reservoir received FDA 510(k) clearance (K number K003551) on July 11 2001, indicating it met the agency’s criteria for safety and effectiveness based on comparison to a predicate device.

• In what setting and how should the reservoir be stored before use?

  It should be stored in a clean, dry environment at room temperature, protected from moisture and physical damage, until it is opened in the operating room for a sterile, single‑use procedure.