NHWClass II

Electrode, Pacing And Cardioversion, Temporary, Epicardial

21 CFR 870.3680 / Cardiovascular

NHW is the FDA product code for Electrode, Pacing And Cardioversion, Temporary, Epicardial, a class II device type, regulated under 21 CFR 870.3680. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2003-02-14, and no recalls.

Classification record

Product code: NHW
Device name: Electrode, Pacing And Cardioversion, Temporary, Epicardial
FDA 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.
Regulation: 21 CFR 870.3680
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code NHW

By decision year

2 clearances under product code NHW with a decision year between 2002 and 2003, 2002 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NHW by decision year
Year	Clearances
2002	1
2003	1

Applicants with the most clearances

Product code NHW

Applicants holding the most 510(k) clearances under product code NHW
Applicant	Clearances
Guidant Corporation, Cardiac Surgery	2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NHW.

Recent clearances

Product code NHW

Recent recalls

Product code NHW

FDA records show no recalls under product code NHW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)