AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
Device Facts
| Record ID | K010471 |
|---|---|
| Device Name | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 |
| Applicant | Irvine Biomedical, Inc. |
| Product Code | DRF · Cardiovascular |
| Decision Date | Jun 6, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1220 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
