NHW

Electrode, Pacing And Cardioversion, Temporary, Epicardial

Product code

NHW

Device name

Electrode, Pacing And Cardioversion, Temporary, Epicardial

Device class

Class 2

21 CFR

21 CFR 870.3680

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).