Venomidicard Infant/ Pediatric Venous Cardiotomy Reservoir

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

510(k) Number

K941215 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Sorin Blood Cardioplegia Console

  Class II

  FDA 510(k) K942582 Active Cleared 27 Jan 1995

• Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy Reservoir with Filt

  Class II

  FDA 510(k) K964907 Active Cleared 21 Aug 1997

• Code 150 Blood Component Collection Set and with Direct Draw Line

  Class II

  FDA 510(k) K963758 Active Cleared 20 Feb 1998

• Dideco Pediatric Arterial Filters

  Class II

  FDA 510(k) K945198 Active Cleared 27 Jun 1995

• Sorin Monolyth Venous Reservoir

  Class II

  FDA 510(k) K933481 Active Cleared 2 Nov 1993

• Sorin Bcd Advanced Pediatric Blood Cardioplegia Systems

  Class II

  FDA 510(k) K936183 Active Cleared 23 Mar 1994

See all devices from Sorin Biomedical, Inc. →

• What is the Venomidicard Infant/Pediatric Venous Cardiotomy Reservoir specifically designed for in surgical settings?

  This device is designed for use during cardiopulmonary bypass procedures in open-heart surgery. It collects venous blood from pediatric and infant patients, ensuring efficient autotransfusion while filtering debris to safeguard the patient’s circulatory system.

• Is the Venomidicard Infant/Pediatric Venous Cardiotomy Reservoir intended for reuse or single-use?

  The device is explicitly intended for single-use in sterile surgical settings. It must not be reused after one procedure to maintain patient safety and sterility.

• How is the Venomidicard Infant/Pediatric Venous Cardiotomy Reservoir supplied, and what does that mean for its handling?

  The device is supplied sterile and packaged for surgical use. This means it should be opened only in a controlled, sterile environment immediately before use, following standard cardiothoracic surgical protocols to prevent contamination.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that imply for its safety standards?

  The Venomidicard Infant/Pediatric Venous Cardiotomy Reservoir received FDA 510(k) clearance (K941215) under the Traditional review pathway, demonstrating substantial equivalence to prior-generation venous reservoirs. This clearance confirms compliance with FDA standards for cardiovascular devices, ensuring it meets established safety and performance criteria for its intended use.