POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
Device Facts
| Record ID | K003452 |
|---|---|
| Device Name | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D |
| Applicant | Ep Technologies, Inc. |
| Product Code | DRF · Cardiovascular |
| Decision Date | Dec 7, 2000 |
| 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.
