# K012763: Sorin Biomedica Smart BCD Vanguard,Surface Modified Blood Cardioplegia System

- Pathway: 510(k) (Abbreviated)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Nov 15, 2001 after 90 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SORIN Biomedica BCD Vanguard™ Blood Cardioplegia System: named in the summary without a submission number

## Indications for use
The Sorin Biomedica SMAR,T® BCD Vanguard™ Surface Modified Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods up to 6 hours. The device allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump, through the extension line and appropriate cannula.

Source page: https://510kreport.com/device/K012763
Methodology: https://510kreport.com/methodology