The following data is part of a premarket notification filed by Catheter Research C/o Burditt, Bowles & Radzius with the FDA for Cri Electronic Control System.
| Device ID | K924125 |
| 510k Number | K924125 |
| Device Name: | CRI ELECTRONIC CONTROL SYSTEM |
| Classification | System, Catheter Control, Steerable |
| Applicant | CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Contact | Brian Grigdby |
| Correspondent | Brian Grigdby CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Product Code | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-17 |
| Decision Date | 1993-05-26 |