CRI ELECTRONIC CONTROL SYSTEM
Device Facts
| Record ID | K924125 |
|---|---|
| Device Name | CRI ELECTRONIC CONTROL SYSTEM |
| Applicant | Catheter Research C/O Burditt, Bowles & Radzius |
| Product Code | DXX · Cardiovascular |
| Decision Date | May 26, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1290 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.