The following data is part of a premarket notification filed by Catheter Research C/o Burditt, Bowles & Radzius with the FDA for Micro-guide System.
| Device ID | K884337 |
| 510k Number | K884337 |
| Device Name: | MICRO-GUIDE SYSTEM |
| Classification | Catheter, Steerable |
| Applicant | CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Contact | R Radzius |
| Correspondent | R Radzius CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-14 |
| Decision Date | 1989-01-05 |