Electrode, Pacing And Cardioversion, Temporary, Epicardial

FDA product code NHW · Class II (moderate risk) · 21 CFR 870.3680 · Cardiovascular

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.

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K024071Guidant Syncrus Internal Cardioversion SystemNHW · Special Guidant Corporation, Cardiac Surgery02/14/2003SE
K020701Syncrus Internal Cardioversion SystemNHW · Traditional Guidant Corporation, Cardiac Surgery05/24/2002SE