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Sorin Biomedica Smart BCD Vanguard Surface Modified Blood Cardioplegia System

by Cobe Cardiovascular, Inc.

510(k) K012763

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Abbreviated NumberK012763 Date15 Nov 2001ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Sorin Biomedica Smart BCD Vanguard Surface Modified Blood Cardioplegia System is a blood cardioplegia device designed to deliver oxygenated blood mixed with a cardioplegic solution. It is intended for use during cardiac surgical procedures to induce temporary cardiac arrest and protect the heart tissue by maintaining perfusion and oxygenation during periods of up to six hours.

This system is used in operating rooms during cardiac surgery to administer cooled or warmed blood cardioplegia solutions. It is a reusable device, supplied as a complete system including tubing, connectors, and a surface-modified component to enhance solution compatibility. The device is classified under FDA regulation 870.2300 and holds a 510(k) clearance (K012763) as substantially equivalent to a predicate device. Storage and handling instructions are not specified in the data but must adhere to standard medical device protocols for sterility and contamination control.

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