NHW
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electrode, Pacing And Cardioversion, Temporary, Epicardial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3680
- Medical specialty
- Cardiovascular
- Flags
- Life-sustaining
- 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.
- Adverse events (MAUDE)
- 2008: 3 · 2009: 4 · 2010: 14 · 2011: 50 · 2012: 23 · 2013: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM (K024071) | Guidant Corporation, Cardiac Surgery | 2003-02-14 | + Add |
| SYNCRUS INTERNAL CARDIOVERSION SYSTEM (K020701) | Guidant Corporation, Cardiac Surgery | 2002-05-24 | + Add |
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Every clearance here is in the API, with alerts when new ones post.