The following data is part of a premarket notification filed by Catheter Research C/o Burditt, Bowles & Radzius with the FDA for Cri Cynosar Catheter.
| Device ID | K924227 |
| 510k Number | K924227 |
| Device Name: | CRI CYNOSAR CATHETER |
| Classification | Catheter, Steerable |
| Applicant | CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Contact | Brian Grigssby |
| Correspondent | Brian Grigssby CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-21 |
| Decision Date | 1993-06-29 |