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 (last 3 years): 2

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).

Official FDA classification page: NHW

Classification and pathway per current FDA publications. Data from openFDA (CC0).