FDA product code NHW: Electrode, Pacing And Cardioversion, Temporary, Epicardial
NHW is the FDA product code for electrode, pacing and cardioversion, temporary, epicardial. It is a Class II device, regulated under 21 CFR 870.3680 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under NHW. The average 510(k) review took 74 days (median 74).
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.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Pacing And Cardioversion, Temporary, Epicardial |
| Device class | Class II |
| Regulation | 21 CFR 870.3680 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every NHW clearance
Top NHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Guidant Corporation, Cardiac Surgery | 2 | 2003-02-14 |
Most recent NHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K024071 | Guidant Corporation, Cardiac Surgery | GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM | 2003-02-14 | 66 |
| K020701 | Guidant Corporation, Cardiac Surgery | SYNCRUS INTERNAL CARDIOVERSION SYSTEM | 2002-05-24 | 81 |
Recalls for NHW devices
openFDA lists no recalls for product code NHW.
Frequently asked questions
What is FDA product code NHW?
NHW is the FDA product code for electrode, pacing and cardioversion, temporary, epicardial. It is a Class II device, regulated under 21 CFR 870.3680 and reviewed by the Cardiovascular panel.
What device class is NHW?
Class II, regulation 21 CFR 870.3680. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHW?
Across 2 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most NHW clearances?
Guidant Corporation, Cardiac Surgery (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NHW
- Run a recall and safety report across every NHW manufacturer
- Watch product code NHW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times