NHW · Class II · 21 CFR 870.3680

FDA Product Code NHW: Electrode, Pacing And Cardioversion, Temporary, Epicardial

The System Is Indicated For Use In Postoperative Cardiac Surgery Patients Who Require Temporary Atrial Or Ventricular Pacing/sensing And/or Atrial Cardioversion. Epicardial Defibrillation Electrodes Can Be Implanted Up To 7 Days.

Leading manufacturers include Guidant Corporation, Cardiac Surgery.

2
Total
2
Cleared
74d
Avg days
2002
Since

FDA 510(k) Cleared Electrode, Pacing And Cardioversion, Temporary, Epicardial Devices (Product Code NHW)

2 devices
1–2 of 2
Cleared Feb 14, 2003
GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K024071
Guidant Corporation, Cardiac Surgery
Cardiovascular · 66d
Cleared May 24, 2002
SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K020701
Guidant Corporation, Cardiac Surgery
Cardiovascular · 81d

About Product Code NHW - Regulatory Context