CRI STEERABLE CATHETER CONTROL SYSTEM

System, Catheter Control, 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 Cri Steerable Catheter Control System.

Pre-market Notification Details

Device IDK904787
510k NumberK904787
Device Name:CRI STEERABLE CATHETER CONTROL SYSTEM
ClassificationSystem, Catheter Control, Steerable
Applicant CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 6131 WEST 80TH ST. Indianapolis,  IN  46278
ContactBrian Grigsby
CorrespondentBrian Grigsby
CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS 6131 WEST 80TH ST. Indianapolis,  IN  46278
Product CodeDXX  
CFR Regulation Number870.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-23
Decision Date1990-12-17

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