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 |