Css-Cardioplegia Safety System

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K973237 ↗

FDA Product Code

DWB

Device Class

Class II

Regulation

21 CFR Part 870.4370

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• BPX80 Bio-Pump (BPX80)

  Class II

  FDA 510(k) K973011 Active Cleared 25 Feb 1998

• Medtronic Bio-Medicus Femoral Cannula/Introducer

  Class II

  FDA 510(k) K924642 Active Cleared 26 Mar 1993

• Bio-Probe(R) Blood Flow Monitoring Syst(Tx-50/50P)

  Class II

  FDA 510(k) K924208 Active Cleared 8 Jul 1993

• Medtronic Bio-Medicus Cannula Insertion Kit

  Class II

  FDA 510(k) K924643 Active Cleared 8 Dec 1992

• Medsat Oxygen Saturation System

  Class II

  FDA 510(k) K941922 Active Cleared 17 Feb 1995

• Medtronic Bio-Medicus Bio-Console Model 540-D

  Class II

  FDA 510(k) K914754 Active Cleared 20 May 1992

See all devices from Medtronic Bio-Medicus, Inc. →