The following data is part of a premarket notification filed by Catheter Research C/o Burditt, Bowles & Radzius with the FDA for Cri Vessel Occlusin System/cri Occlusion Coil.
| Device ID | K914523 |
| 510k Number | K914523 |
| Device Name: | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL |
| Classification | Clip, Vascular |
| 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 | DSS |
| CFR Regulation Number | 870.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-10 |
| Decision Date | 1992-01-10 |