NHW — Electrode, Pacing And Cardioversion, Temporary, Epicardial Class II
FDA product code NHW covers "Electrode, Pacing And Cardioversion, Temporary, Epicardial", a Class II medical device regulated under 21 CFR 870.3680. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NHW
- Device Class
- Class II
- Regulation Number
- 870.3680
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.