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NGBCD & NGBCDP Cardioplegia Delivery Systems

by Sorin Biomedical, Inc.

510(k) K934847

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934847 Date15 Apr 1994ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1009-04 FDA Unclassified (pre-2012) initiated 25 May 2004

    Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.

    • Terminated Z-0960-03 FDA Unclassified (pre-2012) initiated 9 May 2003

    Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTN
Device Class
Class II
Regulation
21 CFR Part 870.4400
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NGBCD & NGBCDP Cardioplegia Delivery Systems are devices used in cardiopulmonary bypass procedures to deliver cardioplegia solutions to the heart. These systems are designed to maintain cardiac function during surgery by providing controlled cooling and perfusion of the myocardium.

The systems are supplied as single-use devices and are intended for use in clinical settings. They are not reusable and must be disposed of after use. The device is not MRI safe and requires proper storage conditions as specified by the manufacturer. The device has received FDA 510(k) clearance under K934847.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NGBCD Cardioplegia Delivery System used for?

    The NGBCD & NGBCDP Cardioplegia Delivery Systems are used in cardiopulmonary bypass procedures to deliver cardioplegia solutions to the heart. They are designed to maintain cardiac function during surgery by providing controlled cooling and perfusion of the myocardium.

  • Are these systems reusable?

    No, the systems are supplied as single-use devices and are not reusable. They must be disposed of after use.

  • What are the storage requirements for these devices?

    The device requires proper storage conditions as specified by the manufacturer. It is not MRI safe.

  • What regulatory approval does this device have?

    The device has received FDA 510(k) clearance under K934847.