Electrode, Pacing And Cardioversion, Temporary, Epicardial
The Temporary Epicardial Pacing and Cardioversion Electrode is a cardiovascular device 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 for up to seven days. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NHW and regulation 21 CFR 870.3680 in the Cardiovascular specialty. Notably, this device is flagged as life-sustaining/life-supporting, reflecting its critical role in postoperative cardiac management.
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Basic Information
- Product Code
- NHW
- Device Class
- FDA class 2
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K024071 | GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM | Feb 14, 2003 | Substantially Equivalent | Guidant Corporation, Cardiac Surgery |
| K020701 | SYNCRUS INTERNAL CARDIOVERSION SYSTEM | May 24, 2002 | Substantially Equivalent | Guidant Corporation, Cardiac Surgery |