MICRO-GUIDE SYSTEM

Catheter, Steerable

CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS

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.

Pre-market Notification Details

Device IDK884337
510k NumberK884337
Device Name:MICRO-GUIDE SYSTEM
ClassificationCatheter, Steerable
Applicant CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 333 WEST WACKER DR. SUITE 1900 Chicago,  IL  60606
ContactR Radzius
CorrespondentR Radzius
CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 333 WEST WACKER DR. SUITE 1900 Chicago,  IL  60606
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-14
Decision Date1989-01-05

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