# K021830: Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System

- Pathway: 510(k) (Special)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Jul 2, 2002 after 28 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934847 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934847: Ngbcd & Ngbcdp Cardioplegia Delivery Systems, Sorin Biomedical, Inc. (1994) Summary page 2.

## Indications for use
The SMART BCD Vanguard Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.

Source page: https://510kreport.com/device/K021830
Methodology: https://510kreport.com/methodology