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 |