FDA and CE Information

Status of Approval

The FDA and CE have not approved the Asporto // Heart Preservation Device for human use.

Hibernicor is currently in pre-IDE discussions with the FDA for pre-clinical studies in a 510k pathway. The predicate device is a standard insulated container used since the 1950’s.

The company maintains a complete design dossier of intellectual property and a quality management system consistent with FDA and CE regulatory requirements.  Specifically including the following:

  • Maintaining work environment to ensure product safety.
  • Managing risk management activities and product design control activities.
  • Establishing inspection protocols and component traceability procedures.
  • Documenting and validating processes for sterility.
  • Verifying the effectiveness of corrective and preventative actions.

Hibernicor is incorporated in the UK as Hibernicor Ltd, which is the first step toward CE approval and device distribution in Europe.

Quality Statement

Our company is committed to maintain and continuously improve product quality, reliability to deliver safe and effective products by complying with all applicable requirements and regulations. We will strive for excellence by maintaining an effective quality management system for the products, services, supplier and customer relationships.