VANGUARD Blood cardioplegia Systems - VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt)

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

510(k) Number

K250150 ↗

FDA Product Code

DTR

Models / Variants

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt)

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)

Device Class

Class II

Regulation

21 CFR Part 870.4240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae

  Class II

  FDA 510(k) K972503 Active Cleared 26 Aug 1997

• Xtra

  Class II

  CE/MDR FDA 510(k) K112245 Active Cleared 6 Sep 2011

• XTRA Autotransfusion System (with XTRA Bowl sets)

  Class II

  FDA 510(k) K240584 Active Cleared 29 Apr 2024

• Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating

  Class II

  FDA 510(k) K061527 Active Cleared 27 Jun 2006

• Retrograde Cardioplegia Cannula, Manual-Inflating, with Malleable or Guidwire Stylet

  Class II

  FDA 510(k) K010974 Active Cleared 18 Jun 2001

• PureFlex Arterial Cannulae

  Class II

  FDA 510(k) K180979 Active Cleared 16 Nov 2018

See all devices from Sorin Group Italia S.R.L. →

• What is the Vanguard Blood Cardioplegia System used for?

  The Vanguard Blood Cardioplegia System is used to deliver blood-based cardioplegia solution during cardiopulmonary bypass procedures to provide myocardial protection by inducing temporary cardiac arrest during cardiac surgery.

• How is the Vanguard Blood Cardioplegia System supplied and what configurations are available?

  The system is supplied as a set or kit and includes configurations with or without a shunt and in a mini size variant, designed for use with blood cardioplegia solutions in cardiovascular surgical settings.

• Is the Vanguard Blood Cardioplegia System reusable or single-use?

  The system is reusable or single-use depending on the component configuration, as determined by its classification as a heat-exchanger device under FDA 510(k) clearance.

• What regulatory pathway was used for the Vanguard Blood Cardioplegia System?

  The Vanguard Blood Cardioplegia System received FDA 510(k) clearance under submission number K250150 and is regulated as a Class II medical device under regulation number 870.4240.

• What temperature and ratio control does the Vanguard Blood Cardioplegia System provide?

  The system regulates and delivers cardioplegic solution at a controlled temperature and ratio, specifically designed to maintain a 4:1 blood-to-crystalloid ratio for effective myocardial protection during surgery.