New Cobe Cardioplegia System

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

510(k) Number

K920312 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cobe Brat 2 Autologous Blood Salvage System With Crit-Line Hematocrit Sampling System

  Class II

  FDA 510(k) K991986 Active Cleared 9 Sep 1999

• Heat Exchanger Modification for Duo and Optima

  Class II

  FDA 510(k) K944267 Active Cleared 28 Apr 1995

• Cobe Patient Monitoring Products

  Class II

  FDA 510(k) K921343 Active Cleared 5 Jan 1993

• Cobe Sampling Site

  Class II

  FDA 510(k) K922484 Active Cleared 3 Dec 1992

• Cobe Cms-Fs Membrane Oxygenator

  Class II

  FDA 510(k) K926467 Active Cleared 9 Nov 1993

• Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator

  Class II

  FDA 510(k) K000255 Active Cleared 25 Apr 2000

See all devices from Cobe Cardiovascular, Inc. →

• What is the Cobe Cardioplegia System used for?

  The Cobe Cardioplegia System is designed for cardiopulmonary support during cardiac surgical procedures. It delivers cardioplegic solutions to arrest and protect the heart by maintaining myocardial perfusion and metabolic stability, thereby reducing ischemic injury and improving postoperative recovery outcomes.

• Is the Cobe Cardioplegia System reusable or single-use?

  The Cobe Cardioplegia System is a reusable device. It requires proper cleaning, disinfection, and maintenance as outlined by the manufacturer to ensure safe and effective use in sterile surgical settings.

• What type of cardioplegia does this system support?

  The system supports the delivery of both cold and warm cardioplegia, allowing clinicians to choose the appropriate temperature for their surgical procedure to optimize myocardial protection.

• Are there any specific storage requirements for this device?

  While the provided data does not specify detailed storage instructions, the Cobe Cardioplegia System is intended for use in sterile surgical environments. It should be stored and maintained according to the manufacturer’s guidelines to preserve its functionality and ensure sterility before use.

• What regulatory pathway does this device follow?

  The Cobe Cardioplegia System holds a 510(k) clearance (K920312) under the FDA’s traditional pathway and is classified as a Class II device under 21 CFR 870.4400. This classification applies to its use in cardiopulmonary bypass and cardioplegia delivery during cardiac surgery.