Reuter Tip Deflecting Wire Guide

Wire, Guide, Catheter

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Reuter Tip Deflecting Wire Guide.

Pre-market Notification Details

Device IDK180830
510k NumberK180830
Device Name:Reuter Tip Deflecting Wire Guide
ClassificationWire, Guide, Catheter
Applicant Cook Incorporated 750 Daniels Way Bloomington,  IN  47402
ContactJennifer L. Allman
CorrespondentJennifer Allman
Cook Incorporated 750 Daniels Way Bloomington,  IN  47402
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-30
Decision Date2018-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00827002086487 K180830 000
00827002078390 K180830 000
00827002077829 K180830 000

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