CRI CYNOSAR CATHETER

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 Cri Cynosar Catheter.

Pre-market Notification Details

Device IDK900320
510k NumberK900320
Device Name:CRI CYNOSAR CATHETER
ClassificationCatheter, 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 CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-23
Decision Date1990-09-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.