The following data is part of a premarket notification filed by Catheter Research C/o Burditt, Bowles & Radzius with the FDA for Cri Steerable Catheter Control System.
| Device ID | K904787 |
| 510k Number | K904787 |
| Device Name: | CRI STEERABLE CATHETER CONTROL SYSTEM |
| Classification | System, Catheter Control, Steerable |
| Applicant | CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Contact | Brian Grigsby |
| Correspondent | Brian Grigsby 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 | 1990-10-23 |
| Decision Date | 1990-12-17 |