Peel-Away Introducer Set

Introducer, Catheter

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Peel-away Introducer Set.

Pre-market Notification Details

Device IDK173685
510k NumberK173685
Device Name:Peel-Away Introducer Set
ClassificationIntroducer, Catheter
Applicant Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington,  IN  47402
ContactColin Jacob
CorrespondentColin Jacob
Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington,  IN  47402
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-01
Decision Date2017-12-20
Summary:summary

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